Integra®

FDA UDI

Class I (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name: Integra® FDA UDI
Generic Name: Self-retaining surgical retractor, reusable FDA UDI
Device Name: Integra®Total Foot System The Jensen Retractor is used to facilitate access to the joint by withdrawing muscles and tissues for exposure to the joint. FDA UDI
Model / Reference: RTKTFS01 FDA UDI
Description: Integra®Total Foot System The Jensen Retractor is used to facilitate access to the joint by withdrawing muscles and tissues for exposure to the joint. FDA UDI

Identifiers

Catalog Number: RTK-TFS-01 FDA UDI
Primary DI / UDI-DI: 10381780247326 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Self-retaining surgical retractor, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Self-retaining surgical retractor, reusable

Integra® by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Self-retaining surgical retractor, reusable.

Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class I
Symmetry Cloward — SYMMETRY SURGICAL INC. · Class II
Life Instruments — Life Instrument Corporation · Class I
Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
SELF RETAINING CORONOID RETRACTOR CHAIN WITH RINGS — W.H. Holden, Inc. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Ascension Orthopedics, Inc.

Sources (1)

FDA UDI d9b32932-d09b-4715-86e7-5880e69c43a0 37 fields · synced Jun 8, 2026