Catalog Number

-

Brand Name

Stratis

Version/Model Number

2057SS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 18, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K041749

Product Code

KMF

Product Code Name

Bandage, liquid

Public Device Record Key

e42e3b91-6c2d-443c-8bfb-512d8e677c23

Public Version Date

March 09, 2021

Public Version Number

3

DI Record Publish Date

July 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-