Catalog Number

420400, 420471

Brand Name

SKIN-PREP Wipes

Version/Model Number

420400, 420471

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NEC

Product Code Name

Bandage, Liquid, Skin Protectant

Public Device Record Key

eed73a93-0aad-4493-9c10-286a51f9455e

Public Version Date

December 21, 2020

Public Version Number

1

DI Record Publish Date

December 11, 2020

Package DI Number

00040565114521

Quantity per Package

50

Contains DI Package

00040565112695

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton 420400