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Arthrex®

FDA UDI

Class II (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name
Arthrex® FDA UDI
Generic Name
Metallic reverse shoulder prosthesis cup FDA UDI
Device Name
Humeral Spacer 33+12mm FDA UDI
Model / Reference
AR-9504-12 FDA UDI
Description
Humeral Spacer 33+12mm FDA UDI

Identifiers

Catalog Number
AR-9504-12 FDA UDI
Primary DI / UDI-DI
00888867406926 FDA UDI
FDA Product Code
PHX FDA UDI
HSD FDA UDI
GMDN Term
Metallic reverse shoulder prosthesis cup FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 FDA UDI
888.3690 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Metallic reverse shoulder prosthesis cup

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

Similar devices

Also classified as Metallic reverse shoulder prosthesis cup.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Arthrex, Inc.

Sources (1)

  • FDA UDI 3068decb-6a5f-4491-b97a-5f1b9930a258 35 fields · synced May 29, 2026