Catalog Number

S-3001

Brand Name

Batrik Skins

Version/Model Number

S-3001

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

-

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

FZZ

Product Code Name

Marker, Skin

Public Device Record Key

f4a5c9a1-214d-40be-818b-8d290549d27a

Public Version Date

October 05, 2020

Public Version Number

1

DI Record Publish Date

September 25, 2020

Package DI Number

00690521002821

Quantity per Package

50

Contains DI Package

00690521014923

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box