Catalog Number

4469

Brand Name

Su-Por Surgical Implant

Version/Model Number

4469

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

K140437

Product Code

FWP

Product Code Name

Prosthesis, Chin, Internal

Public Device Record Key

27aef26d-d302-47fb-a5a5-dcd11686223b

Public Version Date

April 02, 2020

Public Version Number

1

DI Record Publish Date

March 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-