Catalog Number

69606-01

Brand Name

Halyard

Version/Model Number

69606

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

FYC

Product Code Name

GOWN, ISOLATION, SURGICAL

Public Device Record Key

5ad43e6b-b76f-4d66-8dd9-8b2202ed660b

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

August 31, 2017

Package DI Number

30680651696060

Quantity per Package

10

Contains DI Package

10680651696066

Package Discontinue Date

-

Package Status

-

Package Type

CS