Catalog Number

-

Brand Name

SiliGentle Silicone Bordered Foam Dressing

Version/Model Number

3061

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAD

Product Code Name

Dressing, Wound, Occlusive

Public Device Record Key

e4fa9ca5-8446-4866-a5b2-c6e58ced08bf

Public Version Date

June 29, 2021

Public Version Number

1

DI Record Publish Date

June 21, 2021

Package DI Number

00616784306124

Quantity per Package

5

Contains DI Package

00616784306117

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box