Morpheus8 AG609135A_3D
GUDID 17290016633624
Morpheus8 3D 40p Tip
INMODE M.D LTD
Radio-frequency skin contouring system applicator tip| Primary Device ID | 17290016633624 |
| NIH Device Record Key | 3884f255-833d-4cef-a51a-ef2baf9efe5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Morpheus8 |
| Version Model Number | AG609135A_3D |
| Catalog Number | AG609135A_3D |
| Company DUNS | 600417351 |
| Company Name | INMODE M.D LTD |
| Device Count | 1 |
| 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 |
Customer Support Contacts
| 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 |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 17290016633624 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192695
FDA Product Code
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-04 |
| Device Publish Date | 2022-10-27 |
On-Brand Devices [Morpheus8]
| 17290016633624 | Morpheus8 3D 40p Tip |
| 07290016633634 | Morpheus8 Prime 12p Tip |
| 07290016633627 | Morpheus8 Body 40p Tip |
Trademark Results [Morpheus8]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MORPHEUS8 98236166 not registered Live/Pending |
InMode Ltd. 2023-10-23 |
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