Manufacturer IFUs

Welcome to IFUVitals

Your Partner in Accessing Manufacturer Documents

With our IFUVitals module, we are committed to ensuring you have direct access to manufacturer documents, including Instructions for Use (IFUs), straight from the source.

Our Commitment to Safety and Accessibility

In cases where manufacturers do not have IFUs available on their sites, IFUVitals collaborates with them to include their documentation for enhanced safety and compliance. Until the manufacturer uploads the IFU, we temporarily host these critical documents here for your convenience.

Comprehensive Coverage

Our site also serves as a repository for legacy products, "Generic" IFUs, AEMs and SOPs when needed. This ensures that you always have the necessary documentation at your fingertips, whether it's for current or older medical device or biologic.

Thank you for choosing IFUVitals as your trusted resource for accessing manufacturer documents.

Alcon - Monarch 900330314

Alcon - Monarch Forceps W450343c

Alcon - Infinity Ozil 300051142

AMSCO Flexmatic Scrub Station 3797929

Applied Medical Scope Warmer C3001/C3002

Avanos Halyard Mini Stim MS-IVB

Black_Black Surgical-25-0020_Reprocessing_Instructions

Bausch - Sage Tonsil Snare - N6300

Bausch - Westcott Type Utility Scissors - E3322

Bausch - Troutman Needle Holder - Curved - E3839

Bausch - Bishop-Harmon Irrigating Cannula - E4922 039005481-4027105

Bausch - Instruments Non-Powered 4097702 Rev. 2018-01

Bausch - Instruments 4146802 Rev. 2022-10

Bausch - Castroviejo Marking Caliper Curved - E2405

Bausch - Bishop-Harmon Irrigating Cannula - E4922

Bausch - Adapter for Irrigators - E4942

Bausch - Osher-Neumann Corneal Marker 12 line - E9022 12

Bausch - Boies Nasal Fracture Elevator - N4655

Bausch - Castroviejo Fixation Forceps 0.3mm - E1793 US

Bausch - Vannas Curved Capsulotomy Scissors - E3387

Bausch - Scheer Crimper Forceps - N1709 25

Bausch - Scheer Crimper Forceps - N1709 25

Manufacturer Documents

When documents are not available on the manufacturer’s website, they are accessible and displayed below with audits every two months to ensure documents are current. In some cases, an SOP (Standard Operating Procedure) or AEM (Alternate Equipment Maintenance) document is provided when the manufacturer does not have an IFU, is no longer in business, or when we are collaborating with the manufacturer to create a new IFU or rework an existing IFU to meet ISO 13485:2016 requirements as adopted by the FDA.

In this video, we demonstrate the functionality and importance of IFUVitals, designed to ensure compliance with regulatory requirements for Instructions for Use (IFUs) of medical devices, particularly consumables like ultrasound gel. We address the common misconception among manufacturers that packaging directions suffice, highlighting that Class II medical devices require detailed IFUs per FDA regulations. The video showcases how IFUVitals bridges gaps by creating comprehensive Standard Operating Procedures (SOPs) when IFUs are not provided, ensuring safe and effective use. We explain how IFUVitals integrates into workflows, allowing staff to access essential documents easily, and emphasize our commitment to validating products and collaborating with manufacturers and the FDA to maintain compliance. This demonstration underscores our 24/7 support to ensure regulatory adherence and enhance patient safety.

DentalEZ Inc StarDental

Bausch & Lomb - House Scheer Crimper Forcep N1709-25

Bausch - Silver Osteotome Right - N4376

Baxter Artiss Easyspray

Bolder Surgical CoolSeal Mini Instructions for Use_45800 Rev D

CellRight Technologies DermaPure Decellularized Dermal Allograft 071000HD

Cinco - MFG REMOVED from Market General Instrument

CANT Corp Mayostand Attachment DE-98B Tonsil Procedures

Xcelrate UDI Training Documents

IFUVitals Training Manual V1

Why We Validate V1

Sample Tray SOP - multiple IFUs - Ear

Training - Access IFUs - Stryker System 9

Bausch - House Gelfoam® Press - N1705 92L

Depuy Synthes Mitex Expresse W III Flexible Suture Passer 110114_D_eIFU

Depuy Synthes Mitex Surgical Instruments 149958 Rev B

Depuy - Instruments Joint Reconstruction-0902-00-721 Rev. J

Depuy Synthes Orthopaedic Metallic Internal Fixation Devices GP0030-P_eIFU

Draeger DB01273_GA Vapor_2000_enUS_Edition20_Jul-2022_final

Draeger_D-Vapor_D-Vapor_3000

Draeger Apollo 2020

Ecolab 2000 Series Irrigation Solution Warming System

FCI Surgical Instruments

Fresenius Kabi Bone Marrow Collection Stand X6R2105

Gyrus - ACMI USA Elite System Cystourethroscope Sheaths and Bridges REF: E121, E159, M3-30

Gyrus - ACMI CS_B612 Cs-G7

ictec Kong C

icotec Kong vbr

icotec Pedicle

icotec Vader

Karl Storz EOF 111101VN

Karl Storz 11101 SK1 - SK2

Koros Instruments

Marina Medical F-720-002

Medline GemCorner IFU

Medline Sterilization Pouch IFU 2.2

Medtronic StraightShot Microdebrider Cleaning / Sterlization

Mettler Scale MA3002

Mettler Scale MA3002 User Manual

Medtronic StraightShot Microdebrider M4/M5 - 1899200

Moria 65034-M - IFU- Cleaning - Reusable instruments (MULTI)

Standard Operating Procedures (SOP) and Guidelines

Stainless Steel with Silicone SOP

Medline Ultrasonic Gel MDS092005

IUSS Policy

IUSS SOP

Mcconnell Orthopedic Mfg. Co. ASIP #120

MST 67-0077-01 Rev C Osher Malyugin RIng Manipulator

MST 67-0065-02 Rev A MST Handle for Single Use Forceps and Scissors

MST 67-0061-02 Rev A Forceps and Scissors

Orthofix PQ EVO B12-21

Skytron_6702_Hercules_Parts_Catalog

Smith Nephew IFU CSB_8110360-F CLEANINGSTERILIZATION Ortho

Steris 400 IFU 4525691

Steris 400 Manual 2214573

Steris - Caviwave Ultrasonic Washer 1844855

Steris - Century V-116 Manual 2614599

Steris General Cleaning Brush

Smith Nephew ifu_81103630-01_c_cleaningsterilizationcare

Smith Nephew sterilization ortho instrument sets-rigid

Smith Nephew IFU_10601250_G_LENSCameraHead_ML

Smith Nephew IFU_10600778_J_Curved-Guide-System_ML

Smith Nephew IFU_10601461_F_CLEANINGSTERILIZATION Endo

Smith Nephew IFU_1060305_L_Univ-Light-Guides_ML

Smith Nephew QSG_1060354_T_DYONICS-INST_ML

Smith Nephew - IFU_10601439_D_LAPROSCOPES_ML

Smith Nephew MNL_126-99-01_J_SPIDER2_EN

Smith Nephew IFU CSB_8110360-01-D CLEANINGSTERILIZATION Ortho

Steris Channel Cleaning Brush

Steris S2100-Toothbrush Style Brush1968065

Steris Tips Broc 3090 Rev Q

Steris Vividimage W 4K 4231250

Steris Vividimage 4K Surgical Display 4231240

Steris G Series 3161772

Steris G Series Gen 2 4558863

Steris VLED 648510

Stryker Makoplasty Non-Sterile Instruments IFU

Stryker Makoplasty Total Knee User Guide

Stryker System 9 Steris

Stryker System 9 Sterrad

Stryker System 9 Heavy Duty System

Stryker (K2M) MESA Rail Cutter

Stryker VENOM MULTIGEN 2 8400825010

Surgical Direct Stainless Steel

Synthes Care of Instrument and Implant Cases GP0596-H_eIFU

Ulrich Small VBR rep

Ulrich Small VBR

Steris - Century 4525691 IFU REF:V-116

Telea Electronic Engineering S.r.l. Vesalius MCNplus

Teleflex Circumcision Clamp 742110

Thermo Fisher Scientific Orbitrap

Trice Segway Sterilization Instructions

Zimmer_biomet_instrument_care-cleaning-maintenance_sterilization

Zimmer Reusable Instrument Lifespan Manual 1219.4-GLBL-en-Issue Date 2021-04-08

Zimmer Instrument Disassembly and Assembly Manual 1258.5-GLBL-en-Issue Date-2022-10

Zirc 14-hole bur block 50Z403

Spiggle & Theis Medizintechnik GmbH Instruments 10-700-00.

Spiggle & Theis Medizintechnik GmbH Instruments 113.

OICS Opthalmic Guidelines

Stryker System 9 SOP

0 DEG & 30 DEG, 2.9MM STRYKER SCOPE UDI Worksheet

Kangaroo Omni

Mettler Scale

Atlan A350,OPC5908

Trident HD

Fisher 240

Bair Hugger

Symplicity G3

Healthmark TOSI SOP

Xcelrate UDI is the only UDI service provider with their barcode scanning product CEHRT certified under the Office of the National Coordinator (ONC) for Health Information Technology and fully complies with all requirements.

Certification Number:         15.05.05.3045.XCEL.01.01.1.221221

Certification Date:               December 21, 2022