B-P TOTAL SHOULDER SYSTEM - B-P SHOULDER GLENOID BEARING SIZE 4, 2.5 MM - ENDOTEC, INC.

Duns Number:803488357

Device Description: B-P SHOULDER GLENOID BEARING SIZE 4, 2.5 MM THICKNESS, 44 MM HUMERAL HEAD

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More Product Details

Catalog Number

02-02-2444

Brand Name

B-P TOTAL SHOULDER SYSTEM

Version/Model Number

02-02-2444

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K904879

Product Code Details

Product Code

KWS

Product Code Name

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Device Record Status

Public Device Record Key

8cdf99e3-cafb-43c0-a255-e4f7f210ea95

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 17, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ENDOTEC, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 565