Catalog Number

DRC-009-00

Brand Name

Centeze Centesis Catheter

Version/Model Number

DRC-009-00

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

abd95e5f-8649-4849-a3f5-4d546906317e

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

May 23, 2019

Package DI Number

20841268108688

Quantity per Package

100

Contains DI Package

10841268108681

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box