← Back to catalogue

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
Bipolar humeral head outer component FDA UDI
Device Name
B-P SHOULDER SALVAGE HUMERAL STEM W/ BIOCOAT & W/ULTRACOAT - 10 MM FDA UDI
Model / Reference
02-04-0610 FDA UDI
Description
B-P SHOULDER SALVAGE HUMERAL STEM W/ BIOCOAT & W/ULTRACOAT - 10 MM FDA UDI

Identifiers

Catalog Number
02-04-0610 FDA UDI
Primary DI / UDI-DI
00814193025456 FDA UDI
510(k) Number
K982418 FDA UDI
FDA Product Code
KWT FDA UDI
HSD FDA UDI
MJT FDA UDI
GMDN Term
Bipolar humeral head outer component FDA UDI

Classification

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

Dimensions & Sizes

Size
Outer Diameter — 10 Millimeter FDA UDI

Category: Bipolar humeral head outer component

B-P Total Shoulder System 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

K982418 also covers:

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
Endotec, Inc.

Sources (1)

  • FDA UDI 00d243ec-e1b6-471d-834b-64ea0d31ad12 37 fields · synced Jun 1, 2026