Catalog Number

68012-01

Brand Name

Halyard

Version/Model Number

68012

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

e99ec021-61b8-45cf-9cb3-a596596699f5

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

March 02, 2016

Package DI Number

30680651680120

Quantity per Package

2

Contains DI Package

20680651680123

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS