Catalog Number

-

Brand Name

HTR-PEKK

Version/Model Number

PK624639-A

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

K161052

Product Code

KKY

Product Code Name

Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Public Device Record Key

a5750885-2dc1-4ce3-bcac-7452412c8a34

Public Version Date

November 24, 2021

Public Version Number

1

DI Record Publish Date

November 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-