Instrument

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: INSTRUMENT FDA UDI
Generic Name: Femoral head prosthesis trial FDA UDI
Device Name: SPECIALTY ACCOLADE THREADED NECK TRIAL 132 DEG 37mm OFFSET FDA UDI
Model / Reference: I-H1195A237 FDA UDI
Description: SPECIALTY ACCOLADE THREADED NECK TRIAL 132 DEG 37mm OFFSET FDA UDI

Identifiers

Catalog Number: I-H1195A237 FDA UDI
Primary DI / UDI-DI: 07613327332209 FDA UDI
FDA Product Code: LPH FDA UDI
GMDN Term: Femoral head prosthesis trial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3358 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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

Instrument by Howmedica Osteonics Corp. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Howmedica Osteonics Corp.

Sources (1)

FDA UDI 7c61f065-901b-4993-a710-f0a5859ee59e 35 fields · synced May 30, 2026