Catalog Number

-

Brand Name

NA

Version/Model Number

Sterile

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

-

Product Code

PFP

Product Code Name

Silicone Hydrogel For Scar Management

Public Device Record Key

d800cfc8-0079-47ab-90e1-3ce711696b01

Public Version Date

June 13, 2022

Public Version Number

1

DI Record Publish Date

June 03, 2022

Package DI Number

16974795050131

Quantity per Package

10

Contains DI Package

06974795050134

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-