FDA.reportPublic FDA data

CarboJet® CO2 Bone Lavage System

Primary DI
00898142001500
Brand
CarboJet® CO2 Bone Lavage System
Company
Kinamed, Inc.
Model
25-200-0242
Catalog number
25-200-0242
Device description
Femoral Suction Tube
Published
2016-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00898142001500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00898142001500008981420015008981420015000898142001500

GMDN Terms#

Term, Definition table
TermDefinition
Bone cleaning gas-jet Y-piece connectorA Y-shaped tube intended to interface a bone cleaning gas-jet assembly and suction pump to allow gas [usually carbon dioxide (CO2)] and alternatively suction to be delivered to the surgical site during gas jet cleaning of bone during an open surgical orthopaedic procedure. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
184896645
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

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00818720013336SuperCable® ISO-Elastic™ Cerclage System35-880-204035-880-20402022-10-03
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00818720010076SuperCable® Grip and Plate System35-220-201035-220-20102015-10-28
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00898142001906NeuroPro®14-1P1-127714-1P1-12772023-05-15
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00898142001029NeuroPro®14-1P1-081014-1P1-08102015-11-05
00898142001036NeuroPro®14-1P1-081214-1P1-08122015-11-05
00898142001050NeuroPro®14-1P1-041314-1P1-04132015-11-05

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