FDA.reportPublic FDA data

MRI SeedNet®Gold Cryoablation System

Primary DI
07290104830020
Brand
MRI SeedNet®Gold Cryoablation System
Company
GALIL MEDICAL LTD
Model
FPRCH2035
Catalog number
FPRCH2035
Device description
MRI Cryoablation System
Published
2016-08-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
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
K021261000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021261000SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3Galil Medical , Ltd.2002-07-03GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290104830020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290104830020072901048300207290104830020

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, cryogen gas, electronicAn assembly of mains electricity (AC-powered) devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal. The system typically includes an electronic control unit with LCD display to control the flow of cryogen from an attached cylinder, and sometimes to monitor skin temperature; and cryogen-cooled probes to apply the cold to tissues upon contact. It is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) to remove malignant or abnormal benign tissues.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius85 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
531854560
Device count
1
Serial number
true
Manufacturing 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
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
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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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
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