Catalog Number

62640

Brand Name

Halyard

Version/Model Number

62640

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2023

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

FRG

Product Code Name

Wrap, sterilization

Public Device Record Key

3eb5ff1c-3237-4b5a-bffe-518af9cbd951

Public Version Date

January 21, 2021

Public Version Number

5

DI Record Publish Date

April 21, 2016

Package DI Number

30680651626401

Quantity per Package

2

Contains DI Package

20680651626404

Package Discontinue Date

January 01, 2023

Package Status

In Commercial Distribution

Package Type

CS