Catalog Number

79751

Brand Name

Halyard

Version/Model Number

79751

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

5c5b0d60-cf0b-4759-9e40-2a2626a0bbb6

Public Version Date

December 25, 2020

Public Version Number

1

DI Record Publish Date

December 17, 2020

Package DI Number

30680651797514

Quantity per Package

24

Contains DI Package

10680651797510

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS