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 V40 HEAD TRIAL WITH SUTURE HOLES 36MM +5 OFFSET FDA UDI
Model / Reference: I-H21103650 FDA UDI
Description: SPECIALTY V40 HEAD TRIAL WITH SUTURE HOLES 36MM +5 OFFSET FDA UDI

Identifiers

Catalog Number: I-H21103650 FDA UDI
Primary DI / UDI-DI: 07613327376753 FDA UDI
FDA Product Code: KWZ FDA UDI
JDI FDA UDI
LWJ FDA UDI
KWL FDA UDI
KWY FDA UDI
LZO FDA UDI
MAY FDA UDI
MBL FDA UDI
MEH FDA UDI
GMDN Term: Femoral head prosthesis trial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3310 FDA UDI
888.3350 FDA UDI
888.3360 FDA UDI
888.3390 FDA UDI
888.3353 FDA UDI
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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G7® — Biomet Orthopedics, Inc. · Class II
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NovoHip Total Hip System — Novosource, 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 II	Pending data

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Manufacturer

Manufacturer: Howmedica Osteonics Corp.

Sources (1)

FDA UDI 733cdc9f-3a4b-4e6e-8246-5a427ca95f30 35 fields · synced Jun 8, 2026