Omni-Tract®

FDA UDI

Class I (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name: Omni-Tract® FDA UDI
Generic Name: Surgical retraction system, reusable FDA UDI
Device Name: Malleable Fixed Retractor, Square Shaft, 1.5in x 6in (3.8cm x 15.2cm) FDA UDI
Model / Reference: 11516P FDA UDI
Description: Malleable Fixed Retractor, Square Shaft, 1.5in x 6in (3.8cm x 15.2cm) FDA UDI

Identifiers

Catalog Number: 11516P FDA UDI
Primary DI / UDI-DI: 10381780276548 FDA UDI
FDA Product Code: FFO FDA UDI
FGN FDA UDI
GAD FDA UDI
GMDN Term: Surgical retraction system, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.4730 FDA UDI
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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical retraction system, reusable

Omni-Tract® by Integra Lifesciences Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Thompson — Thompson Surgical Instruments · Class I
Thompson — Thompson Surgical Instruments · Class I
GRACEY 14 TALON TOUGH QUIK TIP — American Eagle Instruments · 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

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Manufacturer

Manufacturer: Integra Lifesciences Corp.

Sources (1)

FDA UDI 5693c609-52c9-4406-9efb-7cda9efd9613 35 fields · synced May 30, 2026