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B-P Internal Fixation Accessories

FDA UDI

Class II (US FDA UDI)

by Endotec, Inc.

Identity

Trade Name
B-P INTERNAL FIXATION ACCESSORIES FDA UDI
Generic Name
Total shoulder prosthesis FDA UDI
Device Name
B-P MODULAR EXTENSION SCREW W/O ULTRACOAT FDA UDI
Model / Reference
03-04-0011 FDA UDI
Description
B-P MODULAR EXTENSION SCREW W/O ULTRACOAT FDA UDI

Identifiers

Catalog Number
03-04-0011 FDA UDI
Primary DI / UDI-DI
00814193025647 FDA UDI
510(k) Number
K884789 FDA UDI
FDA Product Code
KWL FDA UDI
GMDN Term
Total shoulder prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3360 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: Total shoulder prosthesisBipolar humeral head outer component

B-P Internal Fixation Accessories by Endotec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bipolar humeral head outer component.

Cleared under the same submission

K884789 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 6fc212b5-a25a-4685-b6b8-37aa006dcd3e 37 fields · synced May 31, 2026