Catalog Number

Code F-SS-08

Brand Name

SUPRAFOIL

Version/Model Number

Code F-SS-08

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K973379,K973379

Product Code

FTM

Product Code Name

Mesh, Surgical

Public Device Record Key

d6c8c2b1-b0ed-4107-8749-3821534e1636

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2017

Package DI Number

10816848023913

Quantity per Package

6

Contains DI Package

00816848023916

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box