Catalog Number

44640

Brand Name

Halyard

Version/Model Number

44640

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 19, 2018

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

9e8c98dc-00e6-4707-b9e0-be3f49a53f9d

Public Version Date

December 22, 2021

Public Version Number

7

DI Record Publish Date

June 01, 2017

Package DI Number

30680651446405

Quantity per Package

4

Contains DI Package

10680651446401

Package Discontinue Date

July 19, 2018

Package Status

Not in Commercial Distribution

Package Type

CS