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Comprehensive Reverse Shoulder

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
COMPREHENSIVE REVERSE SHOULDER FDA UDI
Generic Name
Shoulder prosthesis screw FDA UDI
Model / Reference
115387 FDA UDI

Identifiers

Catalog Number
115387 FDA UDI
Primary DI / UDI-DI
00880304677203 FDA UDI
FDA Product Code
PAO FDA UDI
KWS FDA UDI
PHX FDA UDI
GMDN Term
Shoulder prosthesis screw 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Shoulder prosthesis screw

Comprehensive Reverse Shoulder by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Shoulder prosthesis screw.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Orthopedics, Inc.

Sources (1)

  • FDA UDI a91649ed-399e-46a1-a804-acabf3400a4e 35 fields · synced Jun 1, 2026