Comprehensive Instrumentation

FDA UDI

Class I (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: COMPREHENSIVE INSTRUMENTATION FDA UDI
Generic Name: Humeral head prosthesis trial, reusable FDA UDI
Model / Reference: 405988 FDA UDI

Identifiers

Catalog Number: 405988 FDA UDI
Primary DI / UDI-DI: 00880304472785 FDA UDI
510(k) Number: K080642 FDA UDI
K132239 FDA UDI
K193373 FDA UDI
FDA Product Code: HWT FDA UDI
PAO FDA UDI
KWS FDA UDI
PHX FDA UDI
GMDN Term: Humeral head prosthesis trial, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 FDA UDI
888.3660 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Humeral head prosthesis trial, reusable

Comprehensive Instrumentation by Biomet Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI 72467957-335a-4e3b-80b2-ab3a8052ebbf 35 fields · synced May 30, 2026