Integra®

FDA UDI

Class I (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name: Integra® FDA UDI
Generic Name: External orthopaedic fixation system, reusable FDA UDI
Device Name: Integra® External Fixation System The universal bolt tubular wrench is used to tighten bolts and other parts in the external fixation system. FDA UDI
Model / Reference: 12224504 FDA UDI
Description: Integra® External Fixation System The universal bolt tubular wrench is used to tighten bolts and other parts in the external fixation system. FDA UDI

Identifiers

Catalog Number: 12224504 FDA UDI
Primary DI / UDI-DI: 10381780248071 FDA UDI
FDA Product Code: HXC FDA UDI
GMDN Term: External orthopaedic fixation system, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: External orthopaedic fixation system, reusable

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

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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: Ascension Orthopedics, Inc.

Sources (1)

FDA UDI 6fa1bed9-6fdf-4997-a324-d11ae35eb156 37 fields · synced May 29, 2026