Home GUDID G079C500000A02C0 MIS Golden Isles Pedicle Screw System
Primary DI G079C500000A02C0
Brand MIS Golden Isles Pedicle Screw System
Company Intelivation, LLC
Model C50-0000-A02C
Device description GI MIS Screw Caddy
Published 2023-10-03
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 FSM Tray, Surgical, Instrument NKB Thoracolumbosacral Pedicle Screw System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FSM Tray, Surgical, Instrument General, Plastic Surgery 1 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status G079C500000A02C0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning instrument, reusable A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 037368183 Device count 1 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 00841731153258 ARTEMIS FUZE VILEX LLC FSM 2026-07-22 00841731153265 ARTEMIS TAKEDOWN VILEX LLC FSM 2026-07-22 07290115935578 PER Trial 60 PREMIA SPINE LTD NKB 2026-07-22 07290115935691 PER Trial 50 PREMIA SPINE LTD NKB 2026-07-22 B803PW12A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW14G0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW18A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW20 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW22A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW26A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW30A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW32A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW40A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW6G0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 00840466901035 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901042 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901059 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901066 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901073 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901080 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901097 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901103 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901110 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901127 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901141 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901158 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901165 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901172 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901479 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901486 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21
intelivationtech.com