Catalog Number

SMA53DCKW2

Brand Name

CARDINAL HEALTH

Version/Model Number

SMA53DCKW2

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

fbd56f98-2c10-4d87-aced-76276d6e7f14

Public Version Date

September 29, 2021

Public Version Number

1

DI Record Publish Date

September 21, 2021

Package DI Number

50195594349040

Quantity per Package

3

Contains DI Package

10195594349042

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE