Home GUDID 00810028397828 EF1
Primary DI 00810028397828
Brand EF1
Company Medshape, Inc.
Model DNE-50-150
Device description Drill Bit, 5.0 x 195mm
Published 2024-07-09
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 KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTW Bit, Drill Orthopedic 1 KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810028397828 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 00810028397828 00810028397828 810028397828 0810028397828
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone staple drill bit A thin shaft of metal with a sharp distal end intended to drill a small diameter hole into a small bone for insertion of an orthopaedic bone staple, typically for fixation following osteotomy. It may include markings to help gauge the size of the staple to be used and is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 601306413 Device count 1 Premarket exempt true Lot or batch 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 08032909626380 ST.A.R. 90 F4 CITIEFFE SRL KTT 2026-03-17 08051739535730 ST.A.R. 90 F4 CITIEFFE SRL KTT 2026-03-10 00841732142343 GENERIC Surgical Instruments CTL Medical Corporation HTW 2025-03-31 00841732142350 GENERIC Surgical Instruments CTL Medical Corporation HTW 2025-03-31 00841732142367 GENERIC Surgical Instruments CTL Medical Corporation HTW 2025-03-31