FDA.reportPublic FDA data

IceSeed® Prostate Cryoablation Kit / SeedNet® System

Primary DI
07290104830068
Brand
IceSeed® Prostate Cryoablation Kit / SeedNet® System
Company
GALIL MEDICAL LTD
Model
FPRPR3008
Catalog number
FPRPR3008
Device description
Prostate Kit including Cryoablation Needles, Thermal Sensors, Urethral Warming Set, Prostate Template
Published
2016-08-15
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
GEHUnit, Cryosurgical, Accessories

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010991000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010991000SEEDNET, MODELS FP6T5, FP5T5, FP5T3Galil Medical , Ltd.2001-05-03GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290104830068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290104830068072901048300687290104830068

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Cool, Dry, Place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-287-5000galil.cst@btgplc.com

Regulatory Flags#

DUNS number
531854560
Device count
1
Kit
true
Lot or batch
true
Serial number
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
07290104831195MultiPoint 1.5 Thermal SensorFPRPR4020-02FPRPR4020-022020-10-30
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

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Primary DI, Brand, Company table
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