Catalog Number

-

Brand Name

Halyard

Version/Model Number

77582

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

KKX

Product Code Name

Drape, surgical

Public Device Record Key

a033bb19-a539-4c78-94bb-609bfb4a5a6d

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

March 15, 2017

Package DI Number

30680651775826

Quantity per Package

6

Contains DI Package

20680651775829

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-