Catalog Number

SMA35DC964

Brand Name

CARDINAL HEALTH

Version/Model Number

SMA35DC964

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HCY

Product Code Name

CURETTE, UTERINE

Public Device Record Key

0b49c492-1174-4db7-a99a-b05bb5bc8f0c

Public Version Date

November 15, 2021

Public Version Number

1

DI Record Publish Date

November 05, 2021

Package DI Number

50195594425959

Quantity per Package

2

Contains DI Package

10195594425951

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE