FDA.reportPublic FDA data

NA

Primary DI
10887587024585
Brand
NA
Company
Synthes GmbH
Model
05.000.008
Catalog number
05000008
Device description
HAND PIECE FOR BATTERY POWERED DRIVER
Published
2017-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXLSCREWDRIVER, SKULLPLATE
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
HXXSCREWDRIVER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXLScrewdriver, SkullplateNeurology1
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819890084Direct MarkingGS10
10887587024585PrimaryGS10
H980050000080SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819890084076118198900847611819890084
1088758702458510887587024585

GMDN Terms#

Term, Definition table
TermDefinition
Bone/joint surgical power tool motor, electricA hand-held, electrically-powered component of a surgical power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy to perform a variety of surgical procedures such as drilling or sawing of bones and tough tissues; it is not dedicated to dental procedures. It is designed to accept a motorless handpiece component/attachment (not included) and it is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It may be a micro or macro style device, be cannulated to permit use of a guidewire, include a rechargeable battery, and might be operated with a hand- or foot-switch. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982312327NA68.134.011681340112026-10-16
10886982346704VOLT68.134.111681341112026-10-16
10886982346735VOLT68.134.200681342002026-10-16
10886982363282NA68.045.017680450172026-10-16
10886982363299NA68.045.018680450182026-10-16
10886982363305NA68.045.019680450192026-10-16
10886982363312NA68.045.020680450202026-10-16
10705034753690ChronOS07.801.100.99S0780110099S2015-09-14
10705034753706ChronOS07.801.101.99S0780110199S2015-09-14
10705034753713ChronOS07.801.110.99S0780111099S2015-09-14
10705034753720ChronOS07.801.111.99S0780111199S2015-09-14
10705034753737ChronOS07.801.200.99S0780120099S2015-09-14
10705034799933ChronOS710.002.99S71000299S2015-09-14
10705034799940ChronOS710.014.99S71001499S2015-09-14
10705034799957ChronOS710.019.99S71001999S2015-09-14
10705034799964ChronOS710.021.99S71002199S2015-09-14
10705034799971ChronOS710.025.99S71002599S2015-09-14
10705034799988ChronOS710.026.99S71002699S2015-09-14
10705034799995ChronOS710.027.99S71002799S2015-09-14
10705034800004ChronOS710.038.99S71003899S2015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078396297TruPWR Torque Limiting Attachment Sterile, Single Use 90 in-lbEca Medical InstrumentsHWE2026-10-20
00850078396365PFT Adapter, DS, Mariner,105 in-lb (228-TXRX-009)Eca Medical InstrumentsHWE2026-10-20
00850078396372PFT Adapter, DS, Virata, 85 in-lb (228-TXRX-008)Eca Medical InstrumentsHWE2026-10-20
00199150076451Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080373Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080380Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080397Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00824846013600Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HXX2026-10-19
00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HXX2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00810111227872PinTreace Medical Concepts, Inc.HWE2026-10-16
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-15
00810111228541Drill TackTreace Medical Concepts, Inc.HWE2026-10-15
M697X06402401Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.HXX2026-10-14
00810111227971PinTreace Medical Concepts, Inc.HWE2026-10-12
00810111227988PinTreace Medical Concepts, Inc.HWE2026-10-12
B382SD1455810020Surgical DirectSurgical Direct, Inc.HXX2026-09-29
B382SD1455810030Surgical DirectSurgical Direct, Inc.HXX2026-09-29
10886982345462VOLTSynthes GmbHHXX2026-09-25
00840606197342OmegaSPINAL ELEMENTS, INC.HXX2026-09-22
10888857596719Xia® 3VB Spine LLCHWE2026-05-12
10888857596726Xia® 3VB Spine LLCHWE2026-05-12
10888857596733Xia® 3VB Spine LLCHWE2026-05-12
10888857578135Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578142Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578159Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578166Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578210Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20