Catalog Number

66045564

Brand Name

CUTICERIN 10X10CM

Version/Model Number

66045564

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K842967,K842967,K842967

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

ca090a25-89d0-4e6a-9486-1318d416729e

Public Version Date

December 02, 2020

Public Version Number

1

DI Record Publish Date

November 24, 2020

Package DI Number

05000223456368

Quantity per Package

10

Contains DI Package

05000223456351

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton