FDA.reportPublic FDA data

CarboJet® CO2 Bone Lavage System

Primary DI
10898142001347
Brand
CarboJet® CO2 Bone Lavage System
Company
Kinamed, Inc.
Model
25-100-2001
Catalog number
25-100-2001
Device description
CO2 Tube Set
Published
2016-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FQHLAVAGE, JET

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10898142001347PackageGS16In Commercial Distribution
00898142001340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089814200134710898142001347
00898142001340008981420013408981420013400898142001340

GMDN Terms#

Term, Definition table
TermDefinition
Bone cleaning gas-jet tubing setA dedicated collection of flexible tubing intended to be used as a conduit to deliver carbon dioxide (CO2) from its source to a bone cleaning gas-jet handpiece, during a procedure to clean bone as part of an open surgical orthopaedic procedure. The set includes tubing, connectors, and a filter(s). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184896645
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818720011608SuperCable® Grip and Plate System35-860-206535-860-20652023-06-21
00818720011547SuperCable® Grip and Plate System35-860-102035-860-10202023-06-20
00818720011578SuperCable® Grip and Plate System35-860-202035-860-20202023-06-20
00818720011585SuperCable® Grip and Plate System35-860-203035-860-20302023-06-20
00898142001357SuperCable® Iso-Elastic™ Cerclage System35-100-101035-100-10102015-11-04
00898142001975SuperCable® Iso-Elastic™ Cerclage System37-100-101037-100-10102015-11-04
00818720012438CarboJet XF® Bone Preparation System27-100-114027-100-11402023-07-10
00818720010007SuperCable® Grip and Plate System35-200-101035-200-10102015-10-28
00818720010014SuperCable® Grip and Plate System35-200-102035-200-10202015-10-28
00818720010021SuperCable® Grip and Plate System35-200-103035-200-10302015-10-28
00818720010038SuperCable® Grip and Plate System35-200-104035-200-10402015-10-27
00818720010069SuperCable® Grip and Plate System35-220-101035-220-10102015-10-28
00818720010076SuperCable® Grip and Plate System35-220-201035-220-20102015-10-28
00818720010083SuperCable® Grip and Plate System35-220-201235-220-20122015-10-28
00818720010090SuperCable® Grip and Plate System35-220-301035-220-30102015-10-28
00818720010106SuperCable® Grip and Plate System35-220-301235-220-30122015-10-28
00818720010113SuperCable® Grip and Plate System35-230-451035-230-45102015-10-30
00818720010120SuperCable® Grip and Plate System35-230-451235-230-45122015-10-30
00818720010137SuperCable® Grip and Plate System35-230-451435-230-45142015-10-30
00818720010144SuperCable® Grip and Plate System35-230-451635-230-45162015-10-30

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