Catalog Number

CELERO INTRO-12

Brand Name

Celero Introducer

Version/Model Number

CELERO INTRO-12

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K034021

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

9b426050-850b-4b33-8415-1d3fd8b27192

Public Version Date

July 12, 2019

Public Version Number

4

DI Record Publish Date

August 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-