Catalog Number

-

Brand Name

Halyard

Version/Model Number

48543

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

K153540,K153540,K153540

Product Code

FRG

Product Code Name

Wrap, sterilization

Public Device Record Key

863c236c-fe56-4b38-b2f8-76eff3062c74

Public Version Date

February 03, 2021

Public Version Number

1

DI Record Publish Date

January 26, 2021

Package DI Number

30885632244005

Quantity per Package

5

Contains DI Package

20885632244008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-