Catalog Number

-

Brand Name

CARE SCIENCE

Version/Model Number

017276234701

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAE

Product Code Name

Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Public Device Record Key

95028652-397b-40d1-bce0-86d1ee7a66fa

Public Version Date

May 10, 2019

Public Version Number

1

DI Record Publish Date

May 02, 2019

Package DI Number

20017276234705

Quantity per Package

36

Contains DI Package

00017276234701

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case