Catalog Number

-

Brand Name

mrdh bandage 10 cm x 10 cm

Version/Model Number

400-14

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

K082703,K082703

Product Code

KMF

Product Code Name

Bandage, Liquid

Public Device Record Key

bbdf014f-6633-4a26-af69-3f0276365bcd

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

April 09, 2020

Package DI Number

10389142000114

Quantity per Package

3

Contains DI Package

00389142000117

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box