| Primary Device ID | 17290016633174 |
| NIH Device Record Key | 6f58efc1-3240-4f60-bd60-09fa08b7b402 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FRACTORA |
| Version Model Number | AG601260A |
| Catalog Number | AG601674A |
| Company DUNS | 600417351 |
| Company Name | INMODE M.D LTD |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com | |
| Phone | 1-887-367-4556 |
| contact@inmode.com |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 90 KiloPascal and 110 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290016633177 [Unit of Use] |
| GS1 | 17290016633174 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
[17290016633174]
Dry Heat Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-01-07 |
| Device Publish Date | 2016-10-25 |
| 07290016633054 | Fractora |
| 07290016633023 | Fractora system |
| 17290016633181 | Fractora 60P |
| 17290016633174 | Fractora 60P |