Catalog Number

-

Brand Name

Silicone Sheeting Open Border

Version/Model Number

PR72034-03

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

K840172

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Public Device Record Key

cda3eb9a-3f3f-4fa9-9665-2602ae696f88

Public Version Date

May 10, 2019

Public Version Number

4

DI Record Publish Date

January 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-