IceFORCE® 2.1 CX Cryoablation Needle FPRPR3604
GUDID 07290104831027
2.1mm 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| Primary Device ID | 07290104831027 |
| NIH Device Record Key | 1f8bb21c-8a99-4692-b014-56341bcb44a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IceFORCE® 2.1 CX Cryoablation Needle |
| Version Model Number | FPRPR3604 |
| Catalog Number | FPRPR3604 |
| 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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290104831027 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152133
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 [IceFORCE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ICEFORCE 86541150 4974310 Live/Registered |
Galil Medical Ltd. 2015-02-20 |
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