Catalog Number

67395

Brand Name

Centurion

Version/Model Number

67395

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

HTF

Product Code Name

CURETTE

Public Device Record Key

f149db04-1c85-4ad4-925d-5ecee10a94f6

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

December 31, 2021

Package DI Number

30653160120869

Quantity per Package

20

Contains DI Package

00653160120868

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE