Catalog Number

SACS76Y

Brand Name

Halyard

Version/Model Number

SACS76Y_0006

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OKV

Product Code Name

Obstetrical kit

Public Device Record Key

98a41500-ce92-45bd-a372-e8be1ae70b5f

Public Version Date

September 30, 2022

Public Version Number

1

DI Record Publish Date

September 22, 2022

Package DI Number

20809160386016

Quantity per Package

3

Contains DI Package

10809160386019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-