Catalog Number

50695

Brand Name

Halyard

Version/Model Number

50695

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

4999f9e7-7cd3-4985-a8dd-f5d78fb2b97c

Public Version Date

September 08, 2020

Public Version Number

1

DI Record Publish Date

August 31, 2020

Package DI Number

30680651506956

Quantity per Package

10

Contains DI Package

20680651506959

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS