SMR Shoulder

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name: SMR Shoulder FDA UDI
Generic Name: Reverse shoulder prosthesis head FDA UDI
Device Name: SMR Shoulder - Glenosphere Eccentrical Dia. 42 mm FDA UDI
Model / Reference: 1376.09.051 FDA UDI
Description: SMR Shoulder - Glenosphere Eccentrical Dia. 42 mm FDA UDI

Identifiers

Catalog Number: 1376.09.051 FDA UDI
Primary DI / UDI-DI: 08033390204521 FDA UDI
FDA Product Code: PHX FDA UDI
KWS FDA UDI
KWT FDA UDI
HRY FDA UDI
PAO FDA UDI
GMDN Term: Reverse shoulder prosthesis head FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 FDA UDI
888.3650 FDA UDI
888.3530 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

Category: Reverse shoulder prosthesis head

SMR Shoulder by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Reverse shoulder prosthesis head.

Equinoxe — Exactech, Inc. · Class II
Equinoxe — Exactech, Inc. · Class II
JARVIS Glenoid Rerverse Shoulder Prosthesis — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
Trabecular Metal Reverse Plus™ — Zimmer, Inc. · Class II
AGILON® XO glenosphere neutral incl. screw — implantcast GmbH · Class II
TORNIER PERFORM™ REVERSED — TORNIER, INC. · Class II
Titan™ Reverse Shoulder System — Ascension Orthopedics, Inc. · Class II
Equinoxe — Exactech, 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: Limacorporate

Sources (1)

FDA UDI 8445555b-bd76-4dc9-b628-8b928d39c471 35 fields · synced May 30, 2026