Catalog Number

46875NS

Brand Name

Halyard

Version/Model Number

46875

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

FYA

Product Code Name

GOWN, SURGICAL

Public Device Record Key

2e15f359-338a-405f-b9a1-e4a8b0e07a61

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

October 03, 2019

Package DI Number

30680651468759

Quantity per Package

24

Contains DI Package

20680651468752

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS