Catalog Number

-

Brand Name

Halyard

Version/Model Number

48551

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

K180139,K180139,K180139

Product Code

FRG

Product Code Name

Wrap, sterilization

Public Device Record Key

e759f320-d6ac-4a92-af89-a50b9d140851

Public Version Date

February 05, 2021

Public Version Number

1

DI Record Publish Date

January 28, 2021

Package DI Number

30885632244081

Quantity per Package

10

Contains DI Package

20885632244084

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-