Catalog Number

-

Brand Name

OmniPore Surgical Implant

Version/Model Number

OP82001

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123908

Product Code

KKY

Product Code Name

Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Public Device Record Key

5b042d5c-dac4-464d-9452-05d5903925d2

Public Version Date

May 01, 2020

Public Version Number

1

DI Record Publish Date

April 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-