Catalog Number

-

Brand Name

BioPro Bipolar Head 46mm

Version/Model Number

18138

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K100761

Product Code

KWL

Product Code Name

Prosthesis, Hip, Hemi-, Femoral, Metal

Public Device Record Key

f5830aa9-ddff-4b0a-bfe7-e6a1d7f080bd

Public Version Date

September 09, 2020

Public Version Number

4

DI Record Publish Date

September 16, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-