Home GUDID G079PDG2000 Advantage-C Ti3D, Cervical Interbody
Primary DI G079PDG2000
Brand Advantage-C Ti3D, Cervical Interbody
Company Intelivation, LLC
Model PDG-200
Device description AS Drill Guide
Published 2026-07-10
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name FZX Guide, Surgical, Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FZX Guide, Surgical, Instrument General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status G079PDG2000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Surgical drill guide, reusable A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 037368183 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published G079100120705S1 Advantage C Cervical Interbody Fusion Device 1001.20705S 2026-07-24 G079100140705S1 Advantage C Cervical Interbody Fusion Device 1001.40705S 2026-07-24 G079IVA22025000 Golden Isles Pedicle Screw System IVA-2202-500 2026-07-10 G079IVA22026000 Golden Isles Pedicle Screw System IVA-2202-600 2026-07-10 G079INL1390700 Inlet Bone Fixation System INL-139-070 2024-01-31 G079C2520000650 Golden Isles Pedicle Screw System C25-2000-065 2022-09-23 G079100140712S1 Advantage C Cervical Interbody Fusion Device 1001.40712S 2022-04-15 G079100150706S1 Advantage C Cervical Interbody Fusion Device 1001.50706S 2022-04-15 G079C5011000010 Golden Isles Pedicle Screw System C50-1100-001 2026-04-22 G079C5011000020 Golden Isles Pedicle Screw System C50-1100-002 2026-04-22 G079C5011000030 Golden Isles Pedicle Screw System C50-1100-003 2026-04-22 G079C5020000950 Golden Isles Pedicle Screw System C50-2000-095 2026-04-22 G079C5020001000 Golden Isles Pedicle Screw System C50-2000-100 2026-04-22 G079C5020001050 Golden Isles Pedicle Screw System C50-2000-105 2026-04-22 G079C5070000120 Golden Isles Pedicle Screw System C50-7000-012 2026-04-22 G079OSD000 Golden Isles Pedicle Screw System OSD-00 2026-04-22 G079PAN0010 Golden Isles Pedicle Screw System PAN-001 2026-04-22 G079ADL120P28150 Advantage -LUMBAR Interbody ADL-120P-2815 2026-04-20 G079ADL120P28160 Advantage -LUMBAR Interbody ADL-120P-2816 2026-04-20 G079ADL120P32080 Advantage -LUMBAR Interbody ADL-120P-3208 2026-04-20
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