Catalog Number

-

Brand Name

szosil medical grade silicone sheeting gel for scars

Version/Model Number

1

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K003948,K003948

Product Code

MDA

Product Code Name

Elastomer, Silicone, For Scar Management

Public Device Record Key

80709615-f469-458e-8030-2891c491b5a6

Public Version Date

September 02, 2019

Public Version Number

1

DI Record Publish Date

August 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-