Visual-ICE® Cryoablation System FPRCH6000
GUDID 00867379000006
Cryoablation System
GALIL MEDICAL INC.
General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic| Primary Device ID | 00867379000006 |
| NIH Device Record Key | 47205bd7-c3e6-455e-af05-a1717c0e4533 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Visual-ICE® Cryoablation System |
| Version Model Number | FPRCH6000 |
| Catalog Number | FPRCH6000 |
| Company DUNS | 809529469 |
| Company Name | GALIL MEDICAL INC. |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | |
| 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 |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00867379000006 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113860
FDA Product Code
| GEH | Unit, Cryosurgical, Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-17 |
| Device Publish Date | 2017-02-15 |
On-Brand Devices [Visual-ICE® Cryoablation System]
| 00867379000006 | Cryoablation System |
| 00859019006462 | Cryoablation System |
Trademark Results [Visual-ICE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VISUAL-ICE 85348506 4169198 Live/Registered |
Galil Medical Ltd. 2011-06-16 |
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