Catalog Number

CUR5115

Brand Name

Curad

Version/Model Number

CUR5115

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

Yes

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

NAC

Product Code Name

Dressing, wound, hydrophilic

Public Device Record Key

b1edd1af-bd3c-4d56-848c-f25424743caa

Public Version Date

February 04, 2022

Public Version Number

1

DI Record Publish Date

January 27, 2022

Package DI Number

30888277317608

Quantity per Package

4

Contains DI Package

00888277317607

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

RETAIL INNER PACK