AccessGUDID - DEVICE: CarboJet® CO2 Bone Lavage System (00898142001517)

GUDID

Device Identifier (DI) Information

Brand Name: CarboJet® CO2 Bone Lavage System
Version or Model: 25-200-0244
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 25-200-0244
Company Name: Kinamed, Inc.

Primary DI Number: 00898142001517
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184896645 *Terms of Use

Device Description: Femoral Canal CO2 Nozzle

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64138	Bone cleaning gas-jet nozzle, reusable	A device designed to be attached to the distal end of a bone cleaning gas-jet handpiece to function as a nozzle that produces a jet of gas [usually carbon dioxide (CO2)] from its aperture to clean bone during an open surgical orthopaedic procedure. It is available in many designs, shapes and sizes and may be used with a Y-piece adaptor and suction pump to allow suction through its aperture. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQH	LAVAGE, JET

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 330b43c3-ecfc-416f-bbee-3e6f30741926
Public Version Date: July 20, 2023
Public Version Number: 3
DI Record Publish Date: May 18, 2016