FDA.reportPublic FDA data

MultiPoint 1.5 Thermal Sensor

Primary DI
07290104831195
Brand
MultiPoint 1.5 Thermal Sensor
Company
GALIL MEDICAL LTD
Model
FPRPR4020-02
Catalog number
FPRPR4020-02
Device description
1.5mm Multi-Point Thermal Sensor (MTS)
Published
2020-10-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
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
07290104831195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290104831195072901048311957290104831195

GMDN Terms#

Term, Definition table
TermDefinition
Cryosurgical setA sterile collection of disposable devices used in conjunction with a cryosurgical unit as well as monitoring and other devices to perform a surgical technique that involves freezing a targeted area of tissue to damage and destroy cancer cells in the unwanted portions. A typical set will contain cryo needles, thermal sensors, warmer tubes and catheters, warmer cassette, and tube holders. It is typically used for early stages of prostate cancer or late recurrence of localized prostate cancer after radiotherapy where the prostate is cooled to a temperature of -40° Celsius. Warming of the areas where freezing is not required is simultaneously carried out. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Cool, dry place

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
531854560
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290104830242IceRod® 1.5 90° Cryoablation NeedleFPRPR3204FPRPR32042016-08-15
07290104830259IceSphere® 1.5 90° Cryoablation NeedleFPRPR3260FPRPR32602016-08-15
07290104830310Single-Point 1.5 Thermal Sensor™ MultiPackFPRPR3212FPRPR32122016-08-15
07290104830082IceRod® Prostate Cryoablation Kit / SeedNet® SystemFPRPR3070FPRPR30702016-08-15
07290104830105IceRod® i-Thaw® Prostate Cryoablation Kit / Presice® SystemFPRPR4070FPRPR40702016-08-15
07290104830594IceEDGE® 2.4 90° Cryoablation Needle FPRPR3506FPRPR35062016-08-15
07290104830020MRI SeedNet®Gold Cryoablation SystemFPRCH2035FPRCH20352016-08-15
07290104830884MRI Mobile UnitFPRCH2030FPRCH20302016-08-15
07290104830891MRI Mobile Unit for MRI CryoHit systemFPRCH2032FPRCH20322016-08-15
07290104830914MRI SeedNet®Gold ConsoleFPRCH2033FPRCH20332016-08-15
07290104830099IceRod® He-Thaw Prostate Cryoablation Kit / Presice® System FPRPR4570FPRPR45702016-08-15
07290104830068IceSeed® Prostate Cryoablation Kit / SeedNet® SystemFPRPR3008FPRPR30082016-08-15
07290104831164MultiPoint 1.5 Thermal SensorFPRPR4020FPRPR40202020-08-14
07290104830211IceSphere® 1.5 Cryoablation NeedleFPRPR3258FPRPR32582016-08-15
07290104830327Single-Point 1.5 90° Thermal Sensor™ MultiPack FPRPR3206FPRPR32062016-08-15
07290104830426IceSphere® Cryoablation Needle FPRPR3261FPRPR32612017-02-15
07290104830525Prostate Procedure TemplateSPR000018SPR0000182017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935650621319HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621333HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
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