Primary Device ID | 07290016633238 |
NIH Device Record Key | ce8d8227-62cf-468e-9475-182faf0c5136 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MiniFX |
Version Model Number | AG604696A |
Catalog Number | AG604696A |
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 | 1-887-367-4556 |
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 |
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 | 07290016633238 [Primary] |
GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-10-25 |
07290016633726 - Envision System | 2024-04-01 The Envision Platform with Forma-I, Forma, Morpheus8 and Lumecca Applicators employs two different technologies for various aest |
07290019863021 - Morpheus8C Handpiece | 2024-04-01 Morpheus8C Handpiece is intended for use in dermatologic procedures for electrocoagulation and hemostasis. |
07290019863250 - Ignite RF System | 2024-04-01 The Ignite RF System employs radiofrequency (RF) energy for use in dermatological and general surgical procedures for electrocoa |
07290019863311 - InMode OP | 2024-04-01 The InMode OP System is employing three different technologies for various aesthetic applications – Laser, Intense Pulsed Ligh |
07290019863014 - CelluTite System | 2024-03-27 The CelluTite System with the BodyFX and Plus Handpieces is a medical aesthetic device combining mechanical vacuum skin massagin |
07290019863236 - OptimasMax platform | 2024-03-27 The OptimasMax system is employing three different technologies for various aesthetic applications – Laser, Intense Pulsed Lig |
07290016633658 - FormaI | 2023-11-03 i-Forma Applicator applies RF energy through bipolar electrodes. The applicator has 2 RF electrodes, handle, cable, connector, a |
07290016633719 - FRACTORA 3D-90 Tip | 2023-05-02 Morpheus8V Tip (24 pin) - 4 units in pack |