Catalog Number

-

Brand Name

Halyard

Version/Model Number

95131

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

K080795,K080795

Product Code

FYA

Product Code Name

GOWN, SURGICAL

Public Device Record Key

6f8fe0da-776c-405b-baec-bba0416ea245

Public Version Date

April 07, 2021

Public Version Number

6

DI Record Publish Date

August 19, 2016

Package DI Number

30680651951312

Quantity per Package

28

Contains DI Package

10680651951318

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS