Catalog Number

SP-65000

Brand Name

Silicone Sheeting

Version/Model Number

SP-65000

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"

Yes

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

-

Product Code

MDA

Product Code Name

Elastomer, Silicone, For Scar Management

Public Device Record Key

25c57451-4dc7-4bdf-8b6c-3b6ff25d6f32

Public Version Date

August 23, 2021

Public Version Number

4

DI Record Publish Date

August 09, 2016

Package DI Number

10385640000106

Quantity per Package

10

Contains DI Package

00385640000109

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

SHELF BOX