B-P TOTAL KNEE SYSTEM - B-P KNEE MODULAR FEMORAL COMPONENT W/SCREW, - ENDOTEC, INC.

Duns Number:803488357

Device Description: B-P KNEE MODULAR FEMORAL COMPONENT W/SCREW, W/BIOCOAT, W/ULTRACOAT, RIGHT, SIZE 3

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More Product Details

Catalog Number

04-31-1103

Brand Name

B-P TOTAL KNEE SYSTEM

Version/Model Number

04-31-1103

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

K012702

Product Code Details

Product Code

JWH

Product Code Name

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Device Record Status

Public Device Record Key

43f99a11-b23a-4a5d-ad2b-09d50bdb06b6

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