Catalog Number

25-100-2001

Brand Name

CarboJet® CO2 Bone Lavage System

Version/Model Number

25-100-2001

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

-

Product Code

FQH

Product Code Name

LAVAGE, JET

Public Device Record Key

f9a8f1e2-8a62-468b-a35b-48ec6cbf277c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 18, 2016

Package DI Number

10898142001347

Quantity per Package

6

Contains DI Package

00898142001340

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-