ACTEON F87652
GUDID 03609820876528
Surgical-Osteoplasty
SATELEC
Hard-tissue ultrasonic surgical system| Primary Device ID | 03609820876528 |
| NIH Device Record Key | 529e4335-b847-40b4-8177-3970bea276a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACTEON |
| Version Model Number | CE2 II TIP N STER |
| Catalog Number | F87652 |
| Company DUNS | 381582196 |
| Company Name | SATELEC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | 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 | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com | |
| Phone | +3556340607 |
| info@acteongroup.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03609820876528 [Primary] |
FDA Product Code
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
[03609820876528]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-25 |
| Device Publish Date | 2022-04-15 |
On-Brand Devices [ACTEON]
| 03609820573762 | Universal sterile irrigation lines (x5) enables the use of disinfectant solutions (chlorhexidine |
| 03609820573748 | Universal sterile irrigation line enables the use of disinfectant solutions (chlorhexidine, sodi |
| 03609820573700 | Universal sterile irrigation line enables the use of disinfectant solutions (chlorhexidine, sodi |
| 03609820052519 | The MINILED is a curing light using second generation L.E.D technology. It's one of the only li |
| 03609820052502 | The MINILED is a curing light using second generation L.E.D technology. It's one of the only li |
| 03609820052229 | The MINILED is a curing light using second generation L.E.D technology. It's one of the only li |
| 03609820052212 | The MINILED is a curing light using second generation L.E.D technology. It's one of the only li |
| 03609820876887 | Surgical-Osteoplasty |
| 03609820876870 | Surgical-Osteoplasty |
| 03609820876863 | Surgical-Osteoplasty |
| 03609820876832 | Surgical-Osteotomy |
| 03609820876825 | Surgical-Osteotomy |
| 03609820876795 | Surgical-Osteotomy |
| 03609820876788 | Surgical-Osteotomy |
| 03609820876771 | Surgical-Osteotomy |
| 03609820876894 | Surgical-Osteoplasty |
| 03609820876818 | Surgical-Osteoplasty |
| 03609820876801 | Surgical-Osteotomy |
| 03609820876535 | Surgical-Osteoplasty |
| 03609820876528 | Surgical-Osteoplasty |
| 03609820876511 | Surgical-Osteoplasty |
| 03609820876450 | Surgical-Membrane detachment |
| 03609820876443 | Surgical-Osteotomy |
| 03609820876436 | Surgical-Osteotomy |
| 03609820876429 | Surgical-Osteotomy |
| 03609820876412 | Surgical-Osteotomy |
| 03609820876344 | Surgical-Expansion |
| 03609820876337 | Surgical-Expansion |
| 03609820876320 | Surgical-Expansion |
| 03609820876313 | Surgical-Osteotomy |
| 03609820876306 | Surgical-Osteotomy |
| 03609820876290 | Surgical-Osteotomy |
| 03609820876283 | Surgical-Osteotomy |
| 03609820876276 | Surgical-Syndesmotomy |
| 03609820876269 | Surgical-Syndesmotomy |
| 03609820876252 | Surgical-Syndesmotomy |
| 03609820876238 | Surgical-Syndesmotomy |
| 03609820876221 | Surgical-Membrane detachment |
| 03609820876214 | Surgical-Membrane detachment |
| 03609820876207 | Surgical-Membrane detachment |
| 03609820876191 | Surgical-Osteotomy |
| 03609820876184 | Surgical-Osteotomy |
| 03609820876177 | Surgical-Osteoplasty |
| 03609820876160 | Surgical-Osteotomy |
| 03609820876153 | Surgical-Osteotomy |
| 03609820876146 | Surgical-Osteotomy |
| 03609820876139 | Surgical-Osteotomy |
| 03609820876122 | Surgical-Osteotomy |
| 03609820876115 | Surgical-Osteotomy |
| 03609820876108 | Surgical-Osteotomy |
Trademark Results [ACTEON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACTEON 97821896 not registered Live/Pending |
Acteon LLC 2023-03-03 |
 ACTEON 87573440 5423350 Live/Registered |
Acteon, LLC 2017-08-17 |
 ACTEON 79382718 not registered Live/Pending |
ACTEON 2023-04-25 |
 ACTEON 78587613 3264298 Live/Registered |
ACTEON GROUP LIMITED 2005-03-15 |
 ACTEON 78587435 3241312 Live/Registered |
ACTEON GROUP LIMITED 2005-03-15 |
 ACTEON 78219017 2994161 Live/Registered |
FINANCIERE ACTEON 2003-02-26 |
 ACTEON 78091096 2990189 Dead/Cancelled |
Acteon Technologies, Inc. 2001-10-31 |
 ACTEON 76402145 not registered Dead/Abandoned |
KUMHO Industrial Co., Ltd. 2002-05-01 |
 ACTEON 76338604 not registered Dead/Abandoned |
SAVEDAILY.COM 2001-11-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.