IceEDGE® 2.4 90⁰ Cryoablation Needle FPRPR3506
GUDID 07290104830594
2.4mm 90 degree Cryoablation Needle
GALIL MEDICAL LTD
Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set| Primary Device ID | 07290104830594 |
| NIH Device Record Key | 2541fe29-fed8-4341-87fd-7e65fc78e898 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IceEDGE® 2.4 90⁰ Cryoablation Needle |
| Version Model Number | FPRPR3506 |
| Catalog Number | FPRPR3506 |
| Company DUNS | 531854560 |
| Company Name | GALIL MEDICAL LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com | |
| Phone | 651-287-5000 |
| galil.cst@btgplc.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool, Dry, Place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290104830594 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111859
FDA Product Code
| GEH | Unit, Cryosurgical, Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-15 |
Devices Manufactured by GALIL MEDICAL LTD
| 07290104831195 - MultiPoint 1.5 Thermal Sensor | 2020-11-09 1.5mm Multi-Point Thermal Sensor (MTS) |
| 07290104831164 - MultiPoint 1.5 Thermal Sensor | 2020-08-24 1.5mm Multi-Point Thermal Sensor (MTS) |
| 07290104831133 - IceSphere™ 1.5 CX Cryoablation Needle | 2018-10-23 1.5 mm Cryoablation Needle |
| 07290104830020 - MRI SeedNet®Gold Cryoablation System | 2018-07-06 MRI Cryoablation System |
| 07290104830068 - IceSeed® Prostate Cryoablation Kit / SeedNet® Syst | 2018-07-06 Prostate Kit including Cryoablation Needles, Thermal Sensors, Urethral Warming Set, Prostate Template |
| 07290104830075 - IceSeed® Prostate Cryoablation Kit / Presice® Syst | 2018-07-06 Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template |
| 07290104830082 - IceRod® Prostate Cryoablation Kit / SeedNet® Syste | 2018-07-06 Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template |
| 07290104830099 - IceRod® He-Thaw Prostate Cryoablation Kit / Presic | 2018-07-06 Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template |
Trademark Results [IceEDGE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ICEEDGE 85347656 4147848 Live/Registered |
Galil Medical Ltd. 2011-06-16 |
 ICEEDGE 79212799 5542960 Live/Registered |
ICEPOWER A/S 2017-05-05 |
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