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Orthopedic Fracture Attachment Kit, Berchtold

FDA UDI

Class I (US FDA UDI)

by Composite Manufacturing, Inc.

Identity

Trade Name
Orthopedic Fracture Attachment Kit, Berchtold FDA UDI
Generic Name
Operating table orthopaedic extension, non-powered FDA UDI
Device Name
Orthopedic fracture attachment system used to pull traction and articulate the legs of patient for various procedures. FDA UDI
Model / Reference
3-1000-001 FDA UDI
Description
Orthopedic fracture attachment system used to pull traction and articulate the legs of patient for various procedures. FDA UDI

Identifiers

Catalog Number
OZ 7531775 FDA UDI
Primary DI / UDI-DI
00810105030006 FDA UDI
FDA Product Code
BWN FDA UDI
GMDN Term
Operating table orthopaedic extension, non-powered FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4950 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Operating table orthopaedic extension, non-powered

Orthopedic Fracture Attachment Kit, Berchtold by Composite Manufacturing, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Operating table orthopaedic extension, non-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Composite Manufacturing, Inc.

Sources (1)

  • FDA UDI 0ba62f8e-790e-4bc7-8df8-d13416244818 35 fields · synced May 31, 2026