Primary Device ID | 08057017760856 |
NIH Device Record Key | c6f80885-a842-4b7a-b544-fb87d3c0bd7e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | NIRVANA |
Version Model Number | M117H1 |
Company DUNS | 436887608 |
Company Name | EL.EN. SPA |
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 | 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 |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08057017760856 [Primary] |
GEX | Powered Laser Surgical Instrument |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-26 |
Device Publish Date | 2024-04-18 |
08057017760856 - NIRVANA | 2024-04-26The NIRVANA is a diode laser device indicated for hair removal and permanent hair reduction. The device is provided with two different handpieces that deliver the laser energy to the patient. The NIRVANA electrical specifications are: 100-115V~, 50/60Hz, 1600VA. |
08057017760856 - NIRVANA | 2024-04-26 The NIRVANA is a diode laser device indicated for hair removal and permanent hair reduction. The device is provided with two dif |
08057017760818 - ALLORA PRO | 2024-02-22 The DEKA AGAIN PRO family is a medical laser family equipped with Nd:YAG 1064nm laser. The laser sources deliver the laser outpu |
08057017760719 - DEKA SCULPT | 2023-05-05 The SCULPT is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneo |
08057017760726 - DEKA SmartXide UltraSpeed 2 | 2023-05-05 DEKA SmartXide UltraSpeed 2 is a 10,600 nm CO2 laser devices whit a maximum power of 40W. The laser source delivers the laser ou |
08057017760733 - DEKA TRUIST | 2023-05-05 The DEKA TRUIST is a versatile medical platform that can be equipped with various types of laser and pulsed light handpieces. Th |
08057017760665 - DEKA HELIX | 2023-03-29 The Helix system consists of: • Laser system console (containing the optical bench assembly and laser, the microcontroller con |
08057017760528 - DEKA SMARTPERIO | 2022-04-13 The DEKA SmartPerio is a Nd:YAG laser device for soft tissues intraoral treatments. The DEKA SmartPerio system delivers laser th |
08057017760566 - DEKA MOTUS AZ+ | 2022-04-13 The DEKA Motus AZ+ is a medical device equipped with Alexandrite 755nm laser and Nd:YAG 1064nm laser. The laser sources deliver |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() NIRVANA 98542277 not registered Live/Pending |
NIRVANA CHAUFFE PISCINE INC. 2024-05-09 |
![]() NIRVANA 98110426 not registered Live/Pending |
NIRVANA CENTER MANAGEMENT GROUP, LLC 2023-07-31 |
![]() NIRVANA 98110420 not registered Live/Pending |
NIRVANA CENTER MANAGEMENT GROUP, LLC 2023-07-31 |
![]() NIRVANA 98003878 not registered Live/Pending |
Hahashopby LLC 2023-05-19 |
![]() NIRVANA 97924168 not registered Live/Pending |
Yan, Chuan bo 2023-05-07 |
![]() NIRVANA 97389339 not registered Live/Pending |
M & R Diamond Quilting Co., Inc. 2022-04-29 |
![]() NIRVANA 97305962 not registered Live/Pending |
Nirvana IP, Inc. 2022-03-10 |
![]() NIRVANA 97203946 not registered Live/Pending |
Hardik Patel 2022-01-05 |
![]() NIRVANA 90904573 not registered Live/Pending |
Florida Network of Youth & Family Services, Incorporated 2021-08-26 |
![]() NIRVANA 90728098 not registered Live/Pending |
Frieda's, Inc. 2021-05-21 |
![]() NIRVANA 90630011 not registered Live/Pending |
Alder Creek Beverages LLC 2021-04-07 |
![]() NIRVANA 90609806 not registered Live/Pending |
Trademango Solutions, Inc. 2021-03-29 |