Home GUDID 00190376272511 IdentiTi
Primary DI 00190376272511
Brand IdentiTi
Company ALPHATEC SPINE, INC.
Model 135-400-100
Device description CERVICAL INTERFIXATED DRILL, 10 mm
Published 2021-03-31
Public version status New
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
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTW Bit, Drill Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190376272511 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 00190376272511 00190376272511 190376272511 0190376272511
GMDN Terms# Term, Definition table Term Definition Fluted surgical drill bit, reusable A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 602465783 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 00889795150141 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150158 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150165 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150172 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150189 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150196 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150202 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150219 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150226 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150233 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150240 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795150257 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00889795151728 APEX 3D Total Ankle Replacement System Paragon 28, Inc. HTW 2026-10-12 00190446960324 DYNANAIL HELIX Medshape, Inc. HTW 2026-10-09 00190446960331 DYNANAIL HELIX Medshape, Inc. HTW 2026-10-09 00190446960348 DYNANAIL HELIX Medshape, Inc. HTW 2026-10-09 00190446960409 DYNANAIL HELIX Medshape, Inc. HTW 2026-10-09 00190446960416 DYNANAIL HELIX Medshape, Inc. HTW 2026-10-09 00889024715271 Affixus® Zimmer, Inc. HTW 2026-10-06 10886982345431 VOLT Synthes GmbH HTW 2026-09-25 10886982345479 VOLT Synthes GmbH HTW 2026-09-25 00888867574540 Arthrex® ARTHREX, INC. HTW 2026-09-18 00888867574557 Arthrex® ARTHREX, INC. HTW 2026-09-18 10810128463079 OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x70mm T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION HTW 2026-08-23 10810128463086 OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x100mm T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION HTW 2026-08-23 10810128463185 OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x70mm T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION HTW 2026-08-23 10810128463192 OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x100mm T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION HTW 2026-08-23 00884450681381 Preston™ Merit Medical Systems, Inc. HTW 2026-08-21 00884450681398 Preston™ Merit Medical Systems, Inc. HTW 2026-08-21 00840606191791 Overwatch PCF SPINAL ELEMENTS, INC. HTW 2026-07-31
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