Catalog Number

DRC-002-01

Brand Name

Centeze Centesis Catheter

Version/Model Number

DRC-002-01

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

KGZ

Product Code Name

Accessories, Catheter

Public Device Record Key

7e3b8e10-1195-4548-9668-09b4de45200b

Public Version Date

March 08, 2022

Public Version Number

3

DI Record Publish Date

March 20, 2017

Package DI Number

10841268100357

Quantity per Package

10

Contains DI Package

00841268100350

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box