FDA.reportPublic FDA data

C2 CryoBalloon Swipe Catheter, Standard

Primary DI
00854924006156
Brand
C2 CryoBalloon Swipe Catheter, Standard
Company
C2 THERAPEUTICS, INC.
Model
FG-1015
Catalog number
FG-1015
Device description
C2 CryoBalloon Swipe Catheter with Standard Balloon 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
Sterile
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
00854924006156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854924006156008549240061568549240061560854924006156

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal/biliary dilation balloon catheterA long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. This is a single-use 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
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
00854924006132C2 CryoBalloon Cartridge, LargeFG-1013FG-10132016-10-19
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
10840143902666cryoICE® SystemATRICURE, INC.GEH2026-05-27
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
06974083413313CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413320CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413337CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413412CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413528CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413221CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-22
06974083410718CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413214CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
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