Catalog Number

613210

Brand Name

ACCEL Centesis Catheter

Version/Model Number

613210

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

GCB

Product Code Name

Needle, Catheter

Public Device Record Key

30feeec0-8d34-4b59-b9e9-837a1bcd8740

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 29, 2016

Package DI Number

10813623011417

Quantity per Package

5

Contains DI Package

00813623011410

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-