Catalog Number

SMA21DCNOD

Brand Name

CARDINAL HEALTH

Version/Model Number

SMA21DCNOD

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)

Yes

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

HCY

Product Code Name

CURETTE, UTERINE

Public Device Record Key

74a81cfc-917c-4614-97da-3159e2330cc5

Public Version Date

October 12, 2021

Public Version Number

1

DI Record Publish Date

October 04, 2021

Package DI Number

50195594242211

Quantity per Package

2

Contains DI Package

10195594242213

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE