Catalog Number

5444-3-610

Brand Name

MEDPOR

Version/Model Number

5444-3-610

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K153508

Product Code

FWP

Product Code Name

PROSTHESIS, CHIN, INTERNAL

Public Device Record Key

bf01b8b0-8b63-4083-b056-8c8f6b425caa

Public Version Date

September 16, 2022

Public Version Number

1

DI Record Publish Date

September 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-