FDA.reportPublic FDA data

Oscillating Microsaw G2

Primary DI
07630055505606
Brand
Oscillating Microsaw G2
Company
Bien-Air Surgery SA
Model
1600657
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
17630055505603PackageGS11Not in Commercial Distribution
07630055505606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1763005550560317630055505603
07630055505606076300555056067630055505606

GMDN Terms#

Term, Definition table
TermDefinition
Sawing power tool attachment, oscillatingA 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 an oscillating sawing function when an oscillating saw blade is inserted. This attachment is designed with the cutting teeth arranged in an arc or on a flat plane at its distal end; the teeth are at a 90° angle to its shaft and it cuts when it is moved in a rapid oscillating motion. It is typically made of high-grade stainless steel and synthetic materials and 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
Donation ID number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
27630055509653Long Microsaw Blade 32x0.4mm 15026791502679-0012026-04-21
27630055517672Left Inferior Boarder Osteotomy Blade15027231502723-0012026-04-21
47630055517676Left Inferior Boarder Osteotomy Blade15027231502723-0102026-04-21
27630055509479Short Microsaw Blade 22x0.4mm15026711502671-0012026-04-21
27630055509585Short Microsaw Blade 27x0.4mm15026721502672-0012026-04-21
27630055509592Short Microsaw Blade 32x0.4mm15026731502673-0012026-04-21
27630055509608Short Microsaw Blade 22x0.6mm15026741502674-0012026-04-21
27630055509615Short Microsaw Blade 27x0.6mm15026751502675-0012026-04-21
27630055509622Short Microsaw Blade 32x0.6mm15026761502676-0012026-04-21
27630055509639Long Microsaw Blade 22x0.4mm15026771502677-0012026-04-21
27630055509646Long Microsaw Blade 27x0.4mm15026781502678-0012026-04-21
27630055509660Long Microsaw Blade 22x0.6mm15026801502680-0012026-04-21
27630055509677Long Microsaw Blade 27x0.6mm15026811502681-0012026-04-21
27630055509684Long Microsaw Blade 32x0.6mm15026821502682-0012026-04-21
27630055517641Right Inferior Boarder Osteotomy Blade15027221502722-0012026-04-21
27630055517702Short Oscillating Blade 6x0.4mm15027241502724-0012026-04-21
27630055517733Short Oscillating Blade 9x0.4mm15027251502725-0012026-04-21
27630055517764Long Oscillating Blade 6x0.4mm15027261502726-0012026-04-21
27630055517795Long Oscillating Blade 9x0.4mm15027271502727-0012026-04-21
27630055517825Short Sagittal Blade 6x0.4mm15027431502743-0012026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630055505613Compass 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