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Comprehensive® SRS / Discovery®

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
Comprehensive® SRS / Discovery® FDA UDI
Generic Name
Uncoated elbow humerus prosthesis FDA UDI
Model / Reference
211254 FDA UDI

Identifiers

Catalog Number
211254 FDA UDI
Primary DI / UDI-DI
00880304850347 FDA UDI
510(k) Number
K111746 FDA UDI
K173411 FDA UDI
FDA Product Code
KWT FDA UDI
KWS FDA UDI
JDC FDA UDI
MBF FDA UDI
PHX FDA UDI
GMDN Term
Uncoated elbow humerus prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3650 FDA UDI
888.3660 FDA UDI
888.3150 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
MRI Safety
MR Conditional FDA UDI

Category: Uncoated elbow humerus prosthesis

Comprehensive® SRS / Discovery® by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uncoated elbow humerus prosthesis.

Cleared under the same submission

K111746 also covers:

K173411 also covers:

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 bb36ad46-7497-4b80-8a30-7be6f279efc7 36 fields · synced May 30, 2026