Catalog Number

69353

Brand Name

Halyard

Version/Model Number

69353

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FXP

Product Code Name

COVER, SHOE, OPERATING-ROOM

Public Device Record Key

e9b9022d-db14-48c3-a89d-63a9857b6a40

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

November 16, 2020

Package DI Number

30680651693533

Quantity per Package

3

Contains DI Package

20680651693536

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS