IcePearl® 2.1 CX 90⁰ Cryoablation Needle FPRPR3601
GUDID 07290104830990
2.1mm 90 degree Cryoablation Needle
GALIL MEDICAL LTD
Cryosurgical set| Primary Device ID | 07290104830990 |
| NIH Device Record Key | f02ab33c-c394-4a00-aef5-a509cd5e2abb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IcePearl® 2.1 CX 90⁰ Cryoablation Needle |
| Version Model Number | FPRPR3601 |
| Catalog Number | FPRPR3601 |
| 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 |
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 |
| 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 |
| 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 | 07290104830990 [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 [IcePearl]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ICEPEARL 86541146 4974309 Live/Registered |
Galil Medical Ltd. 2015-02-20 |
 ICEPEARL 75462647 not registered Dead/Abandoned |
Fishery Products International Limited 1998-04-05 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.