Catalog Number

DERMA-UC20

Brand Name

UC Strip™

Version/Model Number

UC-20

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K894205,K894205

Product Code

FPX

Product Code Name

Strip, adhesive, closure, skin

Public Device Record Key

54236703-c9b2-4608-b0ca-0db21dc72eb7

Public Version Date

March 18, 2019

Public Version Number

1

DI Record Publish Date

March 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-