FDA.reportPublic FDA data

NA

Primary DI
07611819102262
Brand
NA
Company
Synthes GmbH
Model
511.801
Catalog number
511801
Device description
OSCILLATING SAW ATTACHMENT II
Published
2016-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819102262Direct MarkingGS10
10886982238054PrimaryGS10
H6795118010SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819102262076118191022627611819102262
1088698223805410886982238054

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
10886982342508VOLT02.535.724025357242026-09-25
10886982342515VOLT02.535.726025357262026-09-25
10886982342522VOLT02.535.728025357282026-09-25
10886982342539VOLT02.535.730025357302026-09-25
10886982342546VOLT02.535.732025357322026-09-25
10886982342553VOLT02.535.734025357342026-09-25
10886982342560VOLT02.535.736025357362026-09-25
10886982342577VOLT02.535.738025357382026-09-25
10886982342584VOLT02.535.740025357402026-09-25
10886982342591VOLT02.535.742025357422026-09-25
10886982342607VOLT02.535.744025357442026-09-25
10886982342614VOLT02.535.746025357462026-09-25
10886982342621VOLT02.535.748025357482026-09-25
10886982342638VOLT02.535.750025357502026-09-25
10886982342645VOLT02.535.752025357522026-09-25
10886982342652VOLT02.535.754025357542026-09-25
10886982342669VOLT02.535.756025357562026-09-25
10886982342676VOLT02.535.758025357582026-09-25
10886982342683VOLT02.535.760025357602026-09-25
10886982344878VOLT02.535.765025357652026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14053613286357Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286388Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286401Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286463Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286500Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286623Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286807Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286838Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286845Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286852Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286869Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286876Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286883Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286890Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286913Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286920Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286937Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613295649Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUMGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613295694Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUMGebr. Brasseler GmbH & Co. KGGFA2026-09-25
14053613286197Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-24
14053613286241Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-24
14053613286173Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-22
14053613286203Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-22
14053613286227Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-22
14053613286289Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-22
14053613286524Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-22
14053613048177KOMET Surgical Saw BladeGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286142Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286159Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286166Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18