Catalog Number

SNS58312

Brand Name

Simpurity

Version/Model Number

SNS58312

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAE

Product Code Name

Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Public Device Record Key

0e67af06-35c1-45db-85ce-d8f4bb38dd06

Public Version Date

December 08, 2021

Public Version Number

1

DI Record Publish Date

November 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-