Catalog Number

-

Brand Name

Cover-Roll®

Version/Model Number

0204100

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KGX

Product Code Name

Tape and bandage, adhesive

Public Device Record Key

025e9d90-7c83-45b3-a04c-29fa2bbaf788

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

04042809021066

Quantity per Package

12

Contains DI Package

04042809021042

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-