Catalog Number

-

Brand Name

EAR DRESSING, ADULT

Version/Model Number

S-1000

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

MHW

Product Code Name

Dressing, Compression

Public Device Record Key

049176cc-fdf4-4ab5-a076-5ba251876e4c

Public Version Date

December 08, 2020

Public Version Number

1

DI Record Publish Date

November 30, 2020

Package DI Number

10850000126135

Quantity per Package

6

Contains DI Package

00850000126138

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-