FDA.reportPublic FDA data

ACTEON

Primary DI
03609820879864
Brand
ACTEON
Company
SATELEC
Model
TIP BS1 XXL M+ STERILE
Catalog number
F87986
Device description
Osteotomy, osteoplasty, decorticating, drilling, shaping and smoothing of the bones andteeth in various surgical procedures, including but not limited to general, orthopedic,otolaryngologic, maxillofacial, oral, hand/foot, neurosurgery, spinal, andplastic/reconstructive surgery.
Published
2019-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163610000PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon Group2017-05-19JDX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03609820879864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03609820879864036098208798643609820879864

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
381582196
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03609820875712ACTEONPZ1 IIF875712026-10-13
03609820875743ACTEONPZ3 IIF875742026-10-13
03609820244846ACTEONCOCOON VET. SPRAY 115VF244842019-12-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972603519682SMTPSMTP Medical Co., Ltd.JDX2026-06-08
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E322036300090MECTRONMECTRON SPAJDX2026-04-20
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