Catalog Number

68160

Brand Name

Halyard

Version/Model Number

68160

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

FRG

Product Code Name

Wrap, sterilization

Public Device Record Key

66a286e3-4e29-4a61-bcd6-57460737fd8b

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

August 31, 2017

Package DI Number

30680651681608

Quantity per Package

2

Contains DI Package

20680651681601

Package Discontinue Date

-

Package Status

-

Package Type

cs