FDA.reportPublic FDA data

NA

Primary DI
07611819498945
Brand
NA
Company
Synthes GmbH
Model
03.010.496
Catalog number
03010496
Device description
T-HANDLE/CANNULATED WITH QUICK COUPLING
Published
2017-10-12
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
HWXTAP, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819498945Direct MarkingGS10
10886982069139PrimaryGS10
H679030104960SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819498945076118194989457611819498945
1088698206913910886982069139

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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
10886982350435NASD03.100.130SD031001302026-02-11
10886982350442NASD03.100.131SD031001312026-02-11
10886982350459NASD03.100.132SD031001322026-02-11
10886982350466NASD03.100.133SD031001332026-02-11
10886982351579NASD399.190SD3991902026-02-11
10886982351661NASD03.010.001SD030100012026-02-11
10886982351678NASD03.010.002SD030100022026-02-11
10886982361288NASD03.405.001SD034050012026-02-11
10886982361295NASD03.100.038SD031000382026-02-11
10887587078502NASD03.501.443SD035014432026-02-11
10887587078571NASD386.902SD3869022026-02-11
10886982351586NASD03.045.001SD030450012026-02-10
10886982351593NASD03.045.003SD030450032026-02-10
10886982362186NASD03.233.016SD032330162026-01-10
10886982362193NASD03.233.017SD032330172026-01-10
10886982362209NASD03.233.018SD032330182026-01-10
10886982362216NASD03.233.019SD032330192026-01-10
10886982361257VOLT60.529.210605292102025-12-16
H9810460002902S0NA04.600.029.02S0460002902S2019-08-20
H9810460002910S0NA04.600.029.10S0460002910S2019-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G832F00503450ACURA Stabilization SystemBioalign Inc.HWX2026-03-09
G832F00503550ACURA Stabilization SystemBioalign Inc.HWX2026-03-09
G832F00503650ACURA Stabilization SystemBioalign Inc.HWX2026-03-09
03662663131674Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131681Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131698Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131704Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131711Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131728Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131735Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131803Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131810Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131827Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131834Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
10886982351661NASynthes GmbHHWX2026-02-11
10886982351678NASynthes GmbHHWX2026-02-11
00810112597417TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHWX2026-02-10
00810112597424TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHWX2026-02-10
00810112597431TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHWX2026-02-10
07640177821324Neo Medical Pedicle screw kitNeo Medical SAHWX2026-02-09
00199150055296Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-26
00199150055227Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055234Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055241Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055258Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055265Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055272Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055289Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055302Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055319Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25