SATELEC F57856
GUDID 03609820578569
General surgery ultrasonic control console
SATELEC
Hard-tissue ultrasonic surgical system| Primary Device ID | 03609820578569 |
| NIH Device Record Key | 98f15c0c-3ea1-4674-bb7b-5c0b2cc9f5b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SATELEC |
| Version Model Number | PIEZOTOME SOLO M+ US |
| Catalog Number | F57856 |
| Company DUNS | 381582196 |
| Company Name | SATELEC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
Customer Support Contacts
| Phone | +33556340607 |
| info@acteongroup.com | |
| Phone | +33556340607 |
| info@acteongroup.com | |
| Phone | +33556340607 |
| info@acteongroup.com | |
| Phone | +33556340607 |
| info@acteongroup.com | |
| Phone | +33556340607 |
| info@acteongroup.com | |
| Phone | +33556340607 |
| info@acteongroup.com | |
| Phone | +33556340607 |
| info@acteongroup.com | |
| Phone | +33556340607 |
| info@acteongroup.com | |
| Phone | +33556340607 |
| info@acteongroup.com | |
| Phone | +33556340607 |
| info@acteongroup.com | |
| Phone | +33556340607 |
| info@acteongroup.com | |
| Phone | +33556340607 |
| info@acteongroup.com | |
| Phone | +33556340607 |
| info@acteongroup.com | |
| Phone | +33556340607 |
| info@acteongroup.com | |
| Phone | +33556340607 |
| info@acteongroup.com | |
| Phone | +33556340607 |
| info@acteongroup.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage 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 | 03609820578569 [Primary] |
| GS1 | 03609821578506 [Direct Marking] |
FDA Product Code
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-21 |
| Device Publish Date | 2022-07-13 |
Devices Manufactured by SATELEC
| 03609820877020 - ACTEON | 2024-04-16 Bone saw with four teeth, used for cutting the ramus cortical bone. Left oriented, it is used to create vertical and horizontal |
| 03609820877037 - ACTEON | 2024-04-16 Bone saw with four teeth, used for cutting the ramus cortical bone. Right oriented, it is used to create vertical and horizonta |
| 03609820877044 - ACTEON | 2024-04-16 Circular scalpel angled at 130°, for osteoplasty, harvesting of bone particles or chips. Ridge osteoplasty, periodontal surger |
| 03609820877068 - ACTEON | 2024-04-16 Curved scalpel particularly recommended for osteoplasty. Remodeling, curettage and harvesting of bone chips. |
| 03609820877075 - ACTEON | 2024-04-16 To be inserted deeply and with great care, along the periodontal ligament, between the root and the alveolar bone. Length of act |
| 03609820877082 - ACTEON | 2024-04-16 9mm cutting depth. Ultra-sharp and robust saw, equipped with four sharpened teeth, intended for in-depth cutting of cortical bon |
| 03609820877099 - ACTEON | 2024-04-16 Long, ultra-sharp saw (15mm), slim profile, equipped with four sharpened teeth, intended for facilitating ramus grafts. |
| 03609820877112 - ACTEON | 2024-04-16 Diamond-coated tip for vestibular bone window cut and for Smoothing sharp edges. |
Trademark Results [SATELEC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SATELEC 73518874 1353896 Live/Registered |
SOCIETE POUR LA CONCEPTION DES APPLICATIONS DES TECHNIQUES ELECTRONIQUES S.A.T.E.L.E.C. 1985-01-23 |
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