Catalog Number

-

Brand Name

Dr.Med

Version/Model Number

10cm×10cm

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

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

K181478,K181478,K181478

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

58d2eefb-d0ae-407b-b975-9f6051bfc047

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 23, 2022

Package DI Number

26958868747002

Quantity per Package

25

Contains DI Package

16958868747005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box