FDA.reportPublic FDA data

ACTEON

Primary DI
03609820876061
Brand
ACTEON
Company
SATELEC
Model
BS2R XL M+ TIP N STER
Catalog number
F87606
Device description
Surgical-Osteotomy
Published
2022-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDXInstrument, Surgical, Sonic And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDXInstrument, Surgical, Sonic And Accessory/AttachmentOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03609820876061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03609820876061036098208760613609820876061

GMDN Terms#

Term, Definition table
TermDefinition
Hard-tissue ultrasonic surgical systemAn assembly of devices designed to use ultrasonic energy to mechanically fragment and cut bone and/or bone cement [e.g., acrylic, polymethylmethacrylate (PMMA)] upon contact during an orthopaedic surgical procedure (e.g., arthroplasty revision, spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It typically includes an ultrasonic energy-producing generator, a handpiece with cutting tip(s)/probe(s) to apply the energy and remove (aspirate) material, and connecting cables.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius70 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+3556340607info@acteongroup.com

Regulatory Flags#

DUNS number
381582196
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03609820876948ACTEONRHL2F876942025-12-12
03609820101286BUSE PERIO MAINT AIR N GO EASYF10128 F10128 2025-12-10
03609820555423SP NEWTRON LED 4K3.7V US EMB F55542F555422025-12-10
03609820876849ACTEONRHL5 M+F876842025-08-04
03609820876917ACTEONRHL4R M+F876912025-08-04
03609820876924ACTEONRHL4L M+F876922025-08-04
03609820876931ACTEONRHL6 M+F876932025-08-04
03609820128184ACTEON05.001.401F128182025-01-17
03609820577104ACTEON05.001.400F577102025-01-17
03609820599359ACTEON03.000.400.05SF599352025-01-17
03609820599366ACTEON03.000.400.01SF599362025-01-17
03609820877334ACTEON03.000.424SF877332025-01-17
03609820877020ACTEON03.000.403SF877022019-12-23
03609820877037ACTEON03.000.404SF877032019-12-23
03609820877044ACTEON03.000.405SF877042019-12-23
03609820877068ACTEON03.000.406SF877062019-12-23
03609820877075ACTEON03.000.407SF877072019-12-23
03609820877082ACTEON03.000.401SF877082019-12-23
03609820877099ACTEON03.000.402SF877092019-12-23
03609820877112ACTEON03.000.409SF877112019-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972603519682SMTPSMTP Medical Co., Ltd.JDX2026-06-08
E322036000220MECTRONMECTRON SPAJDX2026-04-20
E322036300090MECTRONMECTRON SPAJDX2026-04-20
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J021305030131Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030141Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030151Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030161Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030171Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030181Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030191Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030201Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030211Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030221Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030231Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030241Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305000001Piezomed Pro M-PM100W & H Dentalwerk Bürmoos GmbHJDX2025-07-08
J021305010001Piezomed Pro M-PH350W & H Dentalwerk Bürmoos GmbHJDX2025-07-08