Catalog Number

180019

Brand Name

Suprasorb P Sensitive Ag

Version/Model Number

20cm x 20cm no border

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K160022,K160022,K160022,K160022

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

5a864034-03c7-4a34-8206-e67925c892e7

Public Version Date

September 23, 2021

Public Version Number

1

DI Record Publish Date

September 15, 2021

Package DI Number

04063591428376

Quantity per Package

1

Contains DI Package

04063591428345

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pouch