Catalog Number

66045503

Brand Name

CUTICERIN 3X8IN PCH3 B25 Ca6

Version/Model Number

66045503

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

f64dd121-acdc-454f-a964-a790fabbfc6e

Public Version Date

December 02, 2020

Public Version Number

1

DI Record Publish Date

November 24, 2020

Package DI Number

05000223456573

Quantity per Package

25

Contains DI Package

05000223456566

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton