Catalog Number

10-25; 10-25S; 10-61; 10-65

Brand Name

Nuprep Skin Prep Gel

Version/Model Number

10-25; 10-25S; 10-61

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

-

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

K885306,K885306,K885306,K885306,K885306

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

9a4f8b9c-c33c-4229-a716-37bb960ff360

Public Version Date

October 07, 2021

Public Version Number

6

DI Record Publish Date

September 01, 2016

Package DI Number

30891893002247

Quantity per Package

1

Contains DI Package

00891893002246

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack