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B-P Total Shoulder System

FDA UDI

Class II (US FDA UDI)

by Endotec, Inc.

Identity

Trade Name
B-P TOTAL SHOULDER SYSTEM FDA UDI
Generic Name
Total shoulder prosthesis FDA UDI
Device Name
B-P SHOULDER HUMERAL HEAD W/ ULTRACOAT - 52 MM FDA UDI
Model / Reference
02-04-0352 FDA UDI
Description
B-P SHOULDER HUMERAL HEAD W/ ULTRACOAT - 52 MM FDA UDI

Identifiers

Catalog Number
02-04-0352 FDA UDI
Primary DI / UDI-DI
00814193025432 FDA UDI
510(k) Number
K904880 FDA UDI
FDA Product Code
KWS FDA UDI
GMDN Term
Total shoulder prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 FDA UDI
Commercial Distribution
Not 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

Dimensions & Sizes

Size
Outer Diameter — 52 Millimeter FDA UDI

B-P Total Shoulder System by Endotec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K904880 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Endotec, Inc.

Sources (1)

  • FDA UDI 0077a916-7052-4116-b451-d578535a5f00 38 fields · synced Jun 1, 2026