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Integra®

FDA UDI

Class I (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
Integra® FDA UDI
Generic Name
Instrument tray, reusable FDA UDI
Device Name
Integra® Total Foot System The Forefoot and Midfoot Screw Caddy Lid is the top part of the caddy which locks onto the base and keeps content inside the base. FDA UDI
Model / Reference
CSA100108 FDA UDI
Description
Integra® Total Foot System The Forefoot and Midfoot Screw Caddy Lid is the top part of the caddy which locks onto the base and keeps content inside the base. FDA UDI

Identifiers

Catalog Number
CSA-1001-08 FDA UDI
Primary DI / UDI-DI
10381780243489 FDA UDI
FDA Product Code
OJH FDA UDI
GMDN Term
Instrument tray, 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Instrument tray, reusable

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

Similar devices

Also classified as Instrument tray, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascension Orthopedics, Inc.

Sources (1)

  • FDA UDI 11300edd-9c0a-46c8-9538-d93cf6a064ee 37 fields · synced Jun 6, 2026