FDA.reportPublic FDA data

Compass Microsaw G2

Primary DI
07630055505613
Brand
Compass Microsaw G2
Company
Bien-Air Surgery SA
Model
1600658
Published
2023-07-21
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DWISaw, Electrically Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWISaw, Electrically PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17630055505610PackageGS11Not in Commercial Distribution
07630055505613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1763005550561017630055505610
07630055505613076300555056137630055505613

GMDN Terms#

Term, Definition table
TermDefinition
Sawing power tool attachment, reciprocatingA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a reciprocating sawing function when a reciprocating saw blade is inserted. This attachment is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is powered in a rapid reciprocating movement (a back and forth motion like a jigsaw) against the object to be cut. It is typically of the macro design. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481597719
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17630055512236Short Bullnose Blade 22x0.4mm15027312023-02-17
17630055512243Short Bullnose Blade 22x0.4mm1502731-0031502731-0032023-02-17
17630055512250Short Bullnose Blade 22x0.4mm1502731-0101502731-0102023-02-17
17630055512267Short Bullnose Blade 27x0.4mm150273215027322023-02-17
17630055512274Short Bullnose Blade 27x0.4mm1502732-0031502732-0032023-02-17
17630055512281Short Bullnose Blade 27x0.4mm1502732-0101502732-0102023-02-17
17630055512298Short Bullnose Blade 32x0.4mm150273315027332023-02-17
17630055512304Short Bullnose Blade 32x0.4mm1502733-0031502733-0032023-02-17
17630055512311Short Bullnose Blade 32x0.4mm1502733-0101502733-0102023-02-17
17630055512328Short Bullnose Blade 22x0.6mm150273415027342023-02-17
17630055512335Short Bullnose Blade 22x0.6mm1502734-0031502734-0032023-02-17
17630055512342Short Bullnose Blade 22x0.6mm1502734-0101502734-0102023-02-17
17630055512359Short Bullnose Blade 27x0.6mm150273515027352023-02-17
17630055512366Short Bullnose Blade 27x0.6mm1502735-0031502735-0032023-02-17
17630055512373Short Bullnose Blade 27x0.6mm1502735-0101502735-0102023-02-17
17630055512380Short Bullnose Blade 32x0.6mm150273615027362023-02-17
17630055512403Short Bullnose Blade 32x0.6mm1502736-0101502736-0102023-02-17
17630055512410Long Bullnose Blade 22x0.4mm150273715027372023-02-17
17630055512427Long Bullnose Blade 22x0.4mm1502737-0031502737-0032023-02-17
17630055512434Long Bullnose Blade 22x0.4mm1502737-0101502737-0102023-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630055505606Oscillating Microsaw G2Bien-Air Surgery SADWI2023-07-21
07630055505590Osseoscalpel Microsaw G2Bien-Air Surgery SADWI2023-07-21
17630055505603Oscillating Microsaw G2Bien-Air Surgery SADWI2023-07-21
17630055505610Compass Microsaw G2Bien-Air Surgery SADWI2023-07-21
00840124508972LapiLockFUSION ORTHOPEDICS, LLCDWI2023-07-06