CarboJet® CO2 Bone Lavage System - Hand Piece - Kinamed, Inc.

Duns Number:184896645

Device Description: Hand Piece

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More Product Details

Catalog Number

25-200-0200

Brand Name

CarboJet® CO2 Bone Lavage System

Version/Model Number

25-200-0200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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 Details

Product Code

FQH

Product Code Name

LAVAGE, JET

Device Record Status

Public Device Record Key

81a905f3-69e5-42db-8ce1-614648e2f793

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KINAMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 131