Catalog Number

48584

Brand Name

Halyard

Version/Model Number

48584

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"

Yes

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

aa4fa6e4-68e2-4521-a8c6-e67d9f0b6edd

Public Version Date

December 22, 2021

Public Version Number

1

DI Record Publish Date

December 10, 2021

Package DI Number

30680651485848

Quantity per Package

30

Contains DI Package

10680651485844

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS