Charnley

FDA UDI

Class I (US FDA UDI)

by Depuy International Ltd

Identity

Trade Name: CHARNLEY FDA UDI
Generic Name: Femoral stem prosthesis trial FDA UDI
Device Name: CHARNLEY Modular Trial Femoral Stem Round Back 40 Narrow FDA UDI
Model / Reference: 9630-34-000 FDA UDI
Description: CHARNLEY Modular Trial Femoral Stem Round Back 40 Narrow FDA UDI

Identifiers

Catalog Number: 963034000 FDA UDI
Primary DI / UDI-DI: 10603295245384 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Femoral stem prosthesis trial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 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

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: Femoral stem prosthesis trial

Charnley by Depuy International Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femoral stem prosthesis trial.

S-ROM — DEPUY ORTHOPAEDICS, INC. · Class I
ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc. · Class II
S-ROM — DEPUY ORTHOPAEDICS, INC. · Class I
S-ROM — DEPUY ORTHOPAEDICS, INC. · Class I
MALLORY/HEAD MODULAR — Biomet Orthopedics, Inc. · Class I
EXACT REVERSE FP FULL TOOTH RASP — Zimmer, Inc. · Class I
INSTRUMENT — Howmedica Osteonics Corp. · Class I
ZMR® — Zimmer, Inc. · Class II

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: Depuy International Ltd

Sources (1)

FDA UDI 6384d9a1-3478-4ed8-a763-930d725cb7cf 35 fields · synced Jun 1, 2026