Home GUDID 00818069019037
Tecomet
Primary DI 00818069019037
Brand Tecomet
Company TECOMET INC.
Model HD2011260
Device description Driver Assembly, Hex Male 3.2mm 1/4” Male Square Drive
Published 2020-10-08
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HTW Bit, Drill HXX Screwdriver
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTW Bit, Drill Orthopedic 1 HXX Screwdriver Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00818069019037 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00818069019037 00818069019037 818069019037 0818069019037
GMDN Terms# Term, Definition table Term Definition Surgical screwdriver, reusable A 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
Regulatory Flags# DUNS number 078749695 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04052536176700 neon3 Ulrich GmbH & Co. KG HTW 2026-06-08 04052536176717 neon3 Ulrich GmbH & Co. KG HTW 2026-06-08 00196449017355 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017362 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017409 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017416 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017423 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017430 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017447 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017461 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017478 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017485 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017492 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017508 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017515 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017522 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017539 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017546 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017560 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017577 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017584 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00810030811657 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTW 2026-06-01 00810030811671 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTW 2026-06-01 04052536161836 neon3 Ulrich GmbH & Co. KG HTW 2026-05-28 04052536161867 neon3 Ulrich GmbH & Co. KG HTW 2026-05-28 07640221373076 PERLA ® TL SpineArt SA HXX 2026-05-07 08053782783724 BRM TOOL VIP SCREWS INSTRUMENT BRM EXTREMITIES SRL HTW 2026-04-29 08806373894213 LOSPA/BENCOX Corentec Co., Ltd HXX 2026-04-10 08806373899720 LOSPA/BENCOX Corentec Co., Ltd HXX 2026-04-10 08806373887789 BENCOX Surgical Instruments Corentec Co., Ltd HXX 2026-01-12