Catalog Number

-

Brand Name

HEAD & NECK PRESSURE DRESSING

Version/Model Number

S-1010-2

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

48ab030b-0970-442d-9981-cdf009f169a0

Public Version Date

March 13, 2020

Public Version Number

2

DI Record Publish Date

September 21, 2018

Package DI Number

10850000126036

Quantity per Package

6

Contains DI Package

00850000126039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-