Catalog Number

44696NS

Brand Name

Halyard

Version/Model Number

44696

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

K162930,K162930

Product Code

FYA

Product Code Name

GOWN, SURGICAL

Public Device Record Key

91c1883b-17ee-4273-84c9-426d5690f6d3

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

October 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-