Catalog Number

-

Brand Name

Centurion

Version/Model Number

MCL80G2

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

OFD

Product Code Name

Catheter introducer kit

Public Device Record Key

e8b730f9-356e-4e95-a96f-632731539ee4

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 14, 2016

Package DI Number

30653160247214

Quantity per Package

10

Contains DI Package

10653160247210

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX