Catalog Number

DKC20053

Brand Name

PETROLATUM GAUZE®

Version/Model Number

20053

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

-

Product Code

FER

Product Code Name

Anoscope and accessories

Public Device Record Key

178c54c0-5d7b-45ab-bb9f-4882d4390ab4

Public Version Date

February 11, 2019

Public Version Number

2

DI Record Publish Date

October 23, 2018

Package DI Number

30381780491716

Quantity per Package

6

Contains DI Package

10381780491712

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case