Catalog Number

DKC77044

Brand Name

Shur-Conform® Oil Emulsion

Version/Model Number

77044

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K921290,K921290

Product Code

GER

Product Code Name

GAUZE, EXTERNAL (WITH DRUG/BIOLOGIC/ANIMAL SOURCE MATERIAL)

Public Device Record Key

9555b0d2-51d0-4bbb-ac57-20c64595bf76

Public Version Date

November 23, 2018

Public Version Number

1

DI Record Publish Date

October 23, 2018

Package DI Number

30381780491808

Quantity per Package

6

Contains DI Package

10381780491804

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case