Home GUDID 00810040689505 LEOS Cannulated Screw System
Primary DI 00810040689505
Brand LEOS Cannulated Screw System
Company Tyber Medical, LLC
Model 76308550
Catalog number 76308550
Device description T15 Driver Large AO
Published 2023-12-08
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 LRZ Screwdriver, surgical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LRZ Screwdriver, Surgical General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810040689505 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 00810040689505 00810040689505 810040689505 0810040689505
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.
Regulatory Flags# DUNS number 010968002 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B8034500040 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034709510 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034709530 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034709540 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034709560 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034709580 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034709610 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803480 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803490 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803500 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803520 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803530 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803540 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803550 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803560 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803580 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803600 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 B8034803620 ORTHOMED ORTHO-MED, INC. LRZ 2026-07-14 00196449017348 A.L.P.S. mvX™ Tyber Medical, LLC LRZ 2026-06-04 00196449017379 A.L.P.S. mvX™ Tyber Medical, LLC LRZ 2026-06-04 00196449017386 A.L.P.S. mvX™ Tyber Medical, LLC LRZ 2026-06-04 00196449017393 A.L.P.S. mvX™ Tyber Medical, LLC LRZ 2026-06-04 00196449017454 A.L.P.S. mvX™ Tyber Medical, LLC LRZ 2026-06-04 00196449017553 A.L.P.S. mvX™ Tyber Medical, LLC LRZ 2026-06-04 00841731137951 TITANEX VILEX LLC LRZ 2026-05-15 00841731137968 TITANEX VILEX LLC LRZ 2026-05-15 00841731138149 TITANEX VILEX LLC LRZ 2026-05-15 00841731140784 TITANEX VILEX LLC LRZ 2026-05-15 00841731141927 TITANEX VILEX LLC LRZ 2026-05-15 00841731146816 TITANEX VILEX LLC LRZ 2026-05-15
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