Catalog Number

420-HE-S

Brand Name

OR Specific

Version/Model Number

420-HE-S

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

-

Product Code

PUI

Product Code Name

Drape, Surgical, Exempt

Public Device Record Key

839d457d-24c3-4ee2-9e4e-d6c1f5d35322

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

10841027100178

Quantity per Package

10

Contains DI Package

00841027100171

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-