Affiniti

FDA UDI

Class I (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name: Affiniti FDA UDI
Generic Name: Humeral head prosthesis trial, reusable FDA UDI
Device Name: HUMERAL HEAD TRIAL FDA UDI
Model / Reference: 9723087 FDA UDI
Description: HUMERAL HEAD TRIAL FDA UDI

Identifiers

Catalog Number: 9723087 FDA UDI
Primary DI / UDI-DI: 00846832016051 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Humeral head prosthesis trial, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

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

Dimensions & Sizes

Size: Outer Diameter — 44 Millimeter FDA UDI
Height — 15 Millimeter FDA UDI

Category: Humeral head prosthesis trial, reusable

Affiniti by Tornier, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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BIO-MODULAR CHOICE INSTRUMENTS — Biomet Orthopedics, Inc. · Class I

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: Tornier, Inc.

Sources (1)

FDA UDI 8dc21113-4c9b-4aa1-9cc2-0b9e3dcd4b1f 36 fields · synced Jun 1, 2026