FDA.reportPublic FDA data

HEATfx Microwave Ablation System

Primary DI
00859019006936
Brand
HEATfx Microwave Ablation System
Company
GALIL MEDICAL INC.
Model
FPRCH9000-02
Catalog number
FPRCH9000-02
Device description
Microwave ablation system console
Published
2020-09-24
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
00859019006936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859019006936008590190069368590190069360859019006936

GMDN Terms#

Term, Definition table
TermDefinition
Microwave ablation system generatorA mains electricity (AC-powered) device intended to generate microwave energy for localized non-vascular soft-tissue ablation, typically to treat tumours and/or hydatid cysts. The generator connects via a delivery cable to a probe (not included) for delivery of microwaves to the target tissues. It is intended to be used in percutaneous, laparoscopic, or open surgery procedures to ablate tissue typically in the liver, lung, pancreas and kidney.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius50 Degrees Celsius

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
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
00859019006257Argon Auxiliary Line (3 m) FPRCH6115FPRCH61152016-08-15

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Primary DI, Brand, Company table
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