| Primary Device ID | 07290019863342 |
| NIH Device Record Key | 42112640-3d77-4a31-a71a-0976cdafbbae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | APEX RF System |
| Version Model Number | AG614329A |
| Catalog Number | AG614329A |
| Company DUNS | 600417351 |
| Company Name | INMODE M.D LTD |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
| Phone | 18873674556 |
| contact@inmode.com | |
| Phone | 18873674556 |
| contact@inmode.com | |
| Phone | 18873674556 |
| contact@inmode.com |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 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 Atmospheric Pressure | Between 50 KiloPascal and 110 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290019863342 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-17 |
| Device Publish Date | 2025-01-09 |
| 07290019863342 - APEX RF System | 2025-01-17 Apex RF system employs radiofrequency (RF) energy for use in dermatological procedures. |
| 07290019863342 - APEX RF System | 2025-01-17 Apex RF system employs radiofrequency (RF) energy for use in dermatological procedures. |
| 07290016633573 - Define System | 2025-01-15 The DEFINE System is designed to deliver non-thermal RF energy to the skin and subdermal fat. . |
| 07290019863083 - Morpheus8 Resurfacing TIP | 2024-08-30 Morpheus8 Resurfacing 24pin TIP |
| 07290019863090 - Morpheus8 Prime 12 pin TIP | 2024-08-30 Morpheus8 Prime 12pin Tip |
| 07290019863106 - Morpheus8 40 pin TIP | 2024-08-30 Morpheus8 - 40 Pin TIP |
| 07290019863113 - Morpheus8 24 pin TIP | 2024-08-30 Morpheus8 - 24 Pin TIP |
| 07290019863120 - Morpheus8 Burst Applicator | 2024-08-29 Morpheus8 Burst Applicator ( BLK) |
| 07290019863137 - Morpheus8 Burst Deep Applicator | 2024-08-29 Morpheus8 Burst Deep Applicator (BLUE_BLK) |