← Back to catalogue

Hybrid Glenoid

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
Hybrid Glenoid FDA UDI
Generic Name
Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
Model / Reference
113954 FDA UDI

Identifiers

Catalog Number
113954 FDA UDI
Primary DI / UDI-DI
00880304462489 FDA UDI
FDA Product Code
KWT FDA UDI
KWS FDA UDI
HSD FDA UDI
MBF FDA UDI
GMDN Term
Shoulder glenoid fossa prosthesis, prefabricated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3650 FDA UDI
888.3660 FDA UDI
888.3690 FDA UDI
888.3670 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

Category: Shoulder glenoid fossa prosthesis, prefabricated

Hybrid Glenoid by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Shoulder glenoid fossa prosthesis, prefabricated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biomet Orthopedics, Inc.

Sources (1)

  • FDA UDI ebb8619c-380e-4bbe-afe3-175d952f6b21 35 fields · synced May 30, 2026