S-Rom

FDA UDI

Class I (US FDA UDI)

by Depuy Orthopaedics, Inc.

Identity

Trade Name: S-ROM FDA UDI
Generic Name: Femoral head prosthesis trial FDA UDI
Device Name: S-ROM FEMORAL HEAD TRIAL 26mm +0 FDA UDI
Model / Reference: 87-5918 FDA UDI
Description: S-ROM FEMORAL HEAD TRIAL 26mm +0 FDA UDI

Identifiers

Catalog Number: 875918 FDA UDI
Primary DI / UDI-DI: 10603295218753 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Femoral head 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 head prosthesis trial

S-Rom by Depuy Orthopaedics, 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: Depuy Orthopaedics, Inc.

Sources (1)

FDA UDI dbd65082-e70d-4a59-aac4-e5be4cb1b709 35 fields · synced Jun 8, 2026