PROSENSE™ SYSTEM 100-127 VAC FAS3000000-2
GUDID 07290015487290
PROSENSE™ SYSTEM 100-127 VAC Straight cryohandle
ICECURE MEDICAL LTD
General cryosurgical system, cryogen gas, electronic| Primary Device ID | 07290015487290 |
| NIH Device Record Key | 65793ebc-f1b9-4df4-bb0c-a443aca20ccd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROSENSE™ SYSTEM 100-127 VAC |
| Version Model Number | FAS3000000-2 |
| Catalog Number | FAS3000000-2 |
| Company DUNS | 514758619 |
| Company Name | ICECURE MEDICAL LTD |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| 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
Device Dimensions
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
| Height | 47.24 Inch |
| Width | 19.68 Inch |
| Depth | 27.56 Inch |
| Weight | 150 Kilogram |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
| Handling Environment Atmospheric Pressure | Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290015487290 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183213
FDA Product Code
| GEH | Unit, Cryosurgical, Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-19 |
| Device Publish Date | 2021-08-11 |
On-Brand Devices [PROSENSE™ SYSTEM 100-127 VAC]
| 07290015487160 | FAS3000000 |
| 07290015487290 | PROSENSE™ SYSTEM 100-127 VAC Straight cryohandle |
Trademark Results [PROSENSE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROSENSE 97409689 not registered Live/Pending |
Bendix Commercial Vehicle Systems LLC 2022-05-13 |
 PROSENSE 88453953 not registered Live/Pending |
CHEN, XINLEI 2019-05-31 |
 PROSENSE 87386454 not registered Dead/Abandoned |
Seiko Epson Kabushiki Kaisha 2017-03-27 |
 PROSENSE 86790477 5251758 Live/Registered |
IceCure Medical Ltd. 2015-10-16 |
 PROSENSE 86359606 not registered Dead/Abandoned |
ProMaker Sport Pty Ltd 2014-08-07 |
 PROSENSE 85173986 4177765 Dead/Cancelled |
Global Strategic Solutions LLC 2010-11-10 |
 PROSENSE 85094547 4074886 Live/Registered |
AUTOMATIONDIRECT.COM INC. 2010-07-28 |
 PROSENSE 79119985 4307358 Dead/Cancelled |
HFC Prestige International Holding Switzerland SÃ rl 2012-09-12 |
 PROSENSE 78973064 3849033 Dead/Cancelled |
Biologic Health Solutions Pty Ltd 2006-09-13 |
 PROSENSE 78337870 3074385 Live/Registered |
VisEn Medical, Inc. 2003-12-08 |
 PROSENSE 77475706 3629935 Dead/Cancelled |
AutomationDirect.Com Inc. 2008-05-15 |
 PROSENSE 76215778 not registered Dead/Abandoned |
Vincent, Mark 2001-02-26 |
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