FDA.reportPublic FDA data

Tools-Screws

Primary DI
00842188130199
Brand
Tools-Screws
Company
Trimed, INC.
Model
DVTX-8/110 AO B
Catalog number
DVTX-8/110 AO B
Device description
Torx 8 Driver, 110mm AO Breakaway
Published
2025-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXXSCREWDRIVER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188130199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188130199008421881301998421881301990842188130199

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(661)255-7406info@trimedortho.com

Regulatory Flags#

DUNS number
138041277
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
00842188132513Tools - ScrewsDVTX-8/085 AO NPDVTX-8/085 AO NP2026-07-09
00842188132520Tools - ScrewsDVTX-8/095 AO NPDVTX-8/095 AO NP2026-07-09
00842188132537Tools - WS3WS3-SCREW-BUWS3-SCREW-BU2026-06-23
00842188131981CannCompScrew 2.0mm (SelfDrill)L2026L20262026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)L2028L20282026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)L2030L20302026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)L2032L20322026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)L2034L20342026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)L2036L20362026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)L2038L20382026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)L2040L20402026-06-02
00842188132063Tools - HCSHCS-DCADDYHCS-DCADDY2026-06-02
00842188132070Tools - HCSHCS-DCADDYLIDHCS-DCADDYLID2026-06-02
00842188131288Tools-WFSWFS-CAB3.8WFS-CAB3.82026-05-13
00842188131172Tools - EFSGDOSLEDW-2.3-WGDOSLEDW-2.3-W2026-02-19
00842188131127Tools - WS3WS3-LONGPLATEWS3-LONGPLATE2026-01-28
00842188131134Tools - WS3WS3-LONGPLATE-LIDWS3-LONGPLATE-LID2026-01-28
00842188129773Tools - AFSAFS-HEX3.2CAFS-HEX3.2C2025-07-22
00842188132469Tools- WS3HNDL-TRQ14HNDL-TRQ142026-03-25
00842188131158SledsOSN-W-50OSN-W-502026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150081882Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-10
00199150081899Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-10
00842188132513Tools - ScrewsTrimed, INC.HXX2026-07-09
00842188132520Tools - ScrewsTrimed, INC.HXX2026-07-09
06974940307878endophixSuzhou Endophix Co., Ltd.HXX2026-06-23
008401944961003P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
008401944963773P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
008401944966433P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
008401944969193P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
00889024707726SolidLok®Biomet Orthopedics, LLCHXX2026-06-10
07640221373076PERLA ® TLSpineArt SAHXX2026-05-07
09120125220259Shark Screw® driver aclsurgebright GmbHHXX2026-04-30
08800322708224Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-04-21
08800322758175Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-04-21
08800322758267Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-04-21
08800322758274Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-04-21
08806373894213LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373899720LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373887789BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
08806373892660BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
04719879398700Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-11-26
07640332475294PERLA ®SpineArt SAHXX2025-11-10
07640332475300PERLA ®SpineArt SAHXX2025-11-10
07640332475317PERLA ®SpineArt SAHXX2025-11-10
08059386744253Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-06
08059386742266Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-05
04719962169132Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-10-31
04719962169224Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-10-31
09348215164737Turbine X Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164744Turbine X Driver – RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10