Arthrex®

FDA UDI

Class II (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name: Arthrex® FDA UDI
Generic Name: Total shoulder prosthesis FDA UDI
Device Name: ECLIPSE TI HUMERAL HEAD, SIZE 49/20 FDA UDI
Model / Reference: AR-9349-20T FDA UDI
Description: ECLIPSE TI HUMERAL HEAD, SIZE 49/20 FDA UDI

Identifiers

Catalog Number: AR-9349-20T FDA UDI
Primary DI / UDI-DI: 00888867287242 FDA UDI
FDA Product Code: PKC FDA UDI
QHQ FDA UDI
GMDN Term: Total shoulder prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Total shoulder prosthesis

Arthrex® by Arthrex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total shoulder prosthesis.

B-P TOTAL SHOULDER SYSTEM — ENDOTEC, INC. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
Shoulder Innovations Humeral Stemless System — SHOULDER INNOVATIONS, Inc · Class II
Shoulder Innovations Inset Reverse Total Shoulder — SHOULDER INNOVATIONS, Inc · Class II
Shoulder System — Medacta International · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · 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: Arthrex, Inc.

Sources (1)

FDA UDI f777bd9e-7331-45ab-aea0-c5bdb2127ee6 35 fields · synced May 30, 2026