FDA.reportPublic FDA data

Set OSSEODUO + S120 + RAPIDO

Primary DI
17630055506174
Brand
Set OSSEODUO + S120 + RAPIDO
Company
Bien-Air Surgery SA
Model
1700521
Catalog number
1700521-001
Published
2023-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J00717005210011PreviousHIBCC0
17630055506174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1763005550617417630055506174

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool system control unit, line-poweredA mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481597719
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17630055519419Bur PM2-70 80K steel Ø1.5 St11013692026-02-16
17630055519525Bur PM2-70 80K diam EC Ø4.0x80 St11014342026-02-16
27630055519539Bur PM2-70 80K steel Ø2.0 St11013702026-02-16
17630055519549Bur PM2-70 80K steel Ø2.0x80 St11013972026-02-16
17630055519556Bur PM2-70 80K diam Ø1.5 St11013752026-02-16
17630055519563Bur PM2-70 80K diam Ø1.5x80 St11014012026-02-16
17630055519570Bur PM2-70 80K diam EC Ø5.0x80 St11014202026-02-16
17630055519587Bur PM2-70 80K diamC Ø2.0 St11013812026-02-16
27630055519591Bur PM2-70 80K steel Ø2.5 St11013712026-02-16
17630055519600Bur PM2-70 80K steel Ø2.5x80 St11013982026-02-16
17630055519617Bur PM2-70 80K diamC Ø2.0x80 St11014242026-02-16
17630055519624Bur PM2-70 80K diamC Ø2.5x80 St11014252026-02-16
17630055519631Bur PM2-70 80K diamC Ø3.0x80 St11014172026-02-16
17630055519648Bur PM2-70 80K diamC Ø3.5x80 St11014262026-02-16
17630055519655Bur PM2-70 80K diam Ø2.0 St11013762026-02-16
17630055519662Bur PM2-70 80K diam Ø2.0x80 St11014022026-02-16
27630055519676Bur PM2-70 80K steel Ø3.0 St11013722026-02-16
17630055519686Bur PM2-70 80K steel Ø3x80 St11013992026-02-16
17630055519693Bur PM2-70 80K diamC Ø2.5 St11013822026-02-16
17630055519709Bur PM2-70 80K diamC Ø4.0x80 St11014272026-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150001989MR8MEDTRONIC POWERED SURGICAL SOLUTIONSERL2026-03-09
00763000892951M4MEDTRONIC XOMED, INC.ERL2026-02-28
J021305030001Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030011Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030021Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030031Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030041Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030051Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030061Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030071Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030081Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030091Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030101Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030111Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030121Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030131Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030141Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030151Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030161Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030171Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030181Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030191Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030201Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030211Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030221Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030231Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030241Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
00763000722401MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSERL2025-07-21
J021305000000Piezomed Pro M-PM100W & H Dentalwerk Bürmoos GmbHERL2025-07-08
J021305010000Piezomed Pro M-PH350W & H Dentalwerk Bürmoos GmbHERL2025-07-08