FDA.reportPublic FDA data

C2 CryoBalloon Cartridge, Large

Primary DI
00854924006132
Brand
C2 CryoBalloon Cartridge, Large
Company
C2 THERAPEUTICS, INC.
Model
FG-1013
Catalog number
FG-1013
Device description
C2 CryoBalloon Cartridge for C2 CryoBalloon Ablation System
Published
2016-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEHUnit, Cryosurgical, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEHUnit, Cryosurgical, AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854924006132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854924006132008549240061328549240061320854924006132

GMDN Terms#

Term, Definition table
TermDefinition
High-pressure medical gas tubingA flexible, cylindrical device that is used to deliver and withstand gases under very high pressure, i.e., greater than 200 bar/3000 pounds per square inch (psi). It may be composed of any of several malleable or semi-rigid materials, e.g., plastic, rubber or nylon, and braided with cotton wool and/or stainless steel. It is typically used to transport high pressure compressed medical gas to a pressure regulating device. It is available in various lengths, including standard coil lengths. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
929139249
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854924006064Controller, Full/SwipeFG-1006FG-10062016-10-19
00854924006088Catheter, Full, StandardFG-1008FG-10082016-10-19
00854924006095C2 CryoBalloon Focal Catheter, StandardFG-1009FG-10092016-10-19
00854924006125C2 CryoBalloon Focal ControllerFG-1012FG-10122016-10-19
00854924006156C2 CryoBalloon Swipe Catheter, StandardFG-1015FG-10152016-10-19
00854924006248C2 CryoBalloonFG-1024FG-10242018-03-26
00854924006262C2 CryoBalloonFG-1026FG-10262018-03-26
00854924006279C2 CryoBalloonFG-1027FG-10272018-03-26
00854924006286C2 CryoBalloonFG-1028FG-10282018-03-08
00854924006309C2 CryoBalloonFG-1030FG-10302018-03-08
00854924006316C2 CryoBalloonFG-1031FG-10312018-03-08
00854924006323C2 CryoBalloon Full 8 CatheterFG-1032FG-10322016-10-19
00854924006330C2 CryoBalloon Focal Pear Catheter FG-1033FG-10332016-10-19
00854924006101C2 CryoBalloon Cartridge, RegularFG-1010FG-10102016-10-19
00854924006170C2 CryoBalloonFG-1017FG-10172018-03-08
00854924006118Sidecar External Working ChannelFG-1011FG-10112016-10-19
00854924006163BOA Endoscopic ValveFG-1016FG-10162016-10-19
00854924006187C2 CryoBalloonFG-1018FG-10182018-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10840143902673cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902680cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902697cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902703cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902710cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902727cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902734cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143904343cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143912164AtriCure® cryoICE® BOXATRICURE, INC.GEH2026-05-27
04050147024694ErbeErbe Elektromedizin GmbHGEH2026-05-26
08800073100148TargetCool-eRecensMedical, Inc.GEH2026-05-14
06974083413115CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413122CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
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06974083413528CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
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06974083410718CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
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06974083413511CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413818CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
00860009734814ArtemisEigen Health Services LLCGEH2026-01-28
00860009734821Artemis-TPOSEigen Health Services LLCGEH2026-01-28
00194346615124EquateWAL-MART STORES, INC.GEH2025-12-22
10888853004836Freeze Away Pinpoint Skin Tag RemoverSCHOLL'S WELLNESS COMPANY LLCGEH2025-10-01
10888853004867Freeze Away Sub Zero Wart RemoverSCHOLL'S WELLNESS COMPANY LLCGEH2025-09-10
06935650602042HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08