Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-DC5

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

FZS

Product Code Name

Curette, Surgical, General Use

Public Device Record Key

a451e925-1001-4733-a3e5-61ebcf756ea7

Public Version Date

April 07, 2021

Public Version Number

1

DI Record Publish Date

March 30, 2021

Package DI Number

00612479259881

Quantity per Package

50

Contains DI Package

00612479259874

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box