Catalog Number

2110046

Brand Name

Corin BiPolar-i

Version/Model Number

2110046

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

K183114

Product Code

KWY

Product Code Name

Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Public Device Record Key

354e5160-07e1-4d12-9507-a0a3b40a8dcf

Public Version Date

August 02, 2019

Public Version Number

1

DI Record Publish Date

July 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-