FDA.reportPublic FDA data

COXO

Primary DI
06974267890718
Brand
COXO
Company
Foshan COXO Medical Instrument Co.,Ltd.
Model
C-BLADE
Device description
Gutta Cuts
Published
2024-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZTCutter, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZTCutter, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974267890718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974267890718069742678907186974267890718

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic obturation systemAn assembly of devices intended to be used during endodontic treatment involving root canal obturation procedures. It may be used in a variety of modes, e.g., to provide continuous heat to the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, and to backfill and down pack gutta-percha during endodontic root canal treatment or root canal obturation. It typically consists of a mains electricity (AC-powered) generator that regulates an electrical current used to produce resistive heat via the handpieces for the application of the heat, or extrude gutta-percha during a root canal obturation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
529860171
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974267890107COXOCX207-G2024-12-18
06974267890558COXODB686 NANO2024-12-18
06974267890572COXOC-FILL2024-12-18
06974267890640COXOCX249-212024-12-18
06974267890657COXOCX249-222024-12-18
06974267890671COXOCX249-242024-12-18
06974267890688COXODB3382024-12-18
06974267890886COXOCX207-G2024-12-18
06974267891104COXOC-Sailor Pro2024-07-04
06974267890374COXOC-Smart-I Pro2024-11-05
06974267890442COXOC-ROOT I2024-07-04
06974267890565COXODB686 Swift2024-07-04
06974267890664COXOCX249-232024-07-04
06974267891074COXOC-SMART-I PILOT2024-07-04
06974267891197COXOC-FILL MINI2024-07-04
06974267891203COXOC-FILL MINI2024-07-04
06974267891982COXOCX207-22024-07-04
06974267890039COXOCX207-A2024-03-30
06974267890138COXOCX235-1B2024-03-30
06974267890152COXO CX235-1F2024-03-30

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Primary DI, Brand, Company table
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04049197556552RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZT2025-10-15
05010058080492InstrapacROBINSON HEALTHCARE LIMITEDFZT2025-06-23
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10649111078910Sklar InstrumentsSKLAR CORPORATIONFZT2025-01-21
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00714646000781SutureOutBionix, LLCFZT2024-04-23
00714646001184SutureOutBionix, LLCFZT2024-04-23
10197106247327CARDINAL HEALTHCardinal Health 200, LLCFZT2023-09-14
00818069010997TecometTECOMET INC.FZT2023-08-10
05010058070837InstrapacROBINSON HEALTHCARE LIMITEDFZT2023-08-08
05010058070950InstrapacROBINSON HEALTHCARE LIMITEDFZT2023-08-08