FDA.reportPublic FDA data

HEATfx Cart

Primary DI
00859019006400
Brand
HEATfx Cart
Company
GALIL MEDICAL INC.
Model
FPRCH9010
Catalog number
FPRCH9010
Device description
Microwave Ablation System Accessory
Published
2020-08-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEYSystem, Ablation, Microwave And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEYSystem, Ablation, Microwave And AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859019006400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859019006400008590190064008590190064000859019006400

GMDN Terms#

Term, Definition table
TermDefinition
Electromechanical device/system transport trolleyA mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-287-5000support@galilmedical.com

Regulatory Flags#

DUNS number
809529469
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290104831171HEATfx 2.1 20cm NeedleFPRPR5101-02FPRPR5101-022020-10-30
07290104831188HEATfx 2.1 15cm NeedleFPRPR5102-02FPRPR5102-022020-10-30
00859019006936HEATfx Microwave Ablation SystemFPRCH9000-02FPRCH9000-022020-09-24
00859019006394HEATfx Microwave Ablation SystemFPRCH9000FPRCH90002020-08-14
07290104831140HEATfx 2.1 20cm NeedleFPRPR5101FPRPR51012020-08-14
07290104831157HEATfx 2.1 15cm NeedleFPRPR5102FPRPR51022020-08-14
00859019006318Visual-ICE MRI Cryoablation ConsoleFPRCH7000FPRCH70002018-03-07
00859019006325Visual-ICE MRI Junction Box AssemblyFPRCH7050 FPRCH7050 2018-03-07
00859019006332Visual-ICE MRI Mobile Connection PanelFPRCH7100FPRCH71002018-03-07
00867379000006Visual-ICE® Cryoablation SystemFPRCH6000FPRCH60002017-02-15
00859019006004EZ CONNECT2™ Dual Cylinder Adapter, psiFPRCH4000FPRCH40002016-08-15
00859019006011EZ CONNECT2™ Dual Cylinder Adapter, bar FPRCH4001FPRCH40012016-08-15
00859019006028Argon Supply Line (8 m), bar FPRCH6100FPRCH61002016-08-15
00859019006035Helium Supply Line (8 m), bar FPRCH6101FPRCH61012016-08-15
00859019006042Argon Supply Line (3 m), bar FPRCH6103FPRCH61032016-08-15
00859019006059Helium Supply Line (3 m), barFPRCH6105FPRCH61052016-08-15
00859019006066Argon Supply Line (8 m), psi FPRCH6106FPRCH61062016-08-15
00859019006073Helium Supply Line (8 m), psi FPRCH6107FPRCH61072016-08-15
00859019006233Gas Supply Line (8 m) FPRCH6108FPRCH61082016-08-15
00859019006240Gas Supply Line (3 m) FPRCH6109FPRCH61092016-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935650621319HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
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06935650621357HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621371HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622613HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622620HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622637HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622651HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622668HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622682HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622699HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622729HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650623344HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650623351HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650624327HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626048HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626451HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626468HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
05060359560971MicroBlate FineCREO MEDICAL LIMITEDNEY2025-05-05
05060359560490MicroBlate FineCREO MEDICAL LIMITEDNEY2025-05-05
06954414601015Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601022Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601039Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601046Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601053Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601060Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601077Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601084Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601107Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601121Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14