Home GUDID M719GL201TL0 SIros-X
Primary DI M719GL201TL0
Brand SIros-X
Company Genesys Orthopedics Systems LLC
Model 1
Catalog number GL201T-L
Device description Large T-Ratchet Handle
Published 2026-07-23
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 NKB Thoracolumbosacral Pedicle Screw System OLO Orthopedic Stereotaxic Instrument OUR Sacroiliac Joint Fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2 OLO Orthopedic Stereotaxic Instrument Neurology 2 OUR Sacroiliac Joint Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M719GL201TL0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Surgical instrument handle, non-torque-limiting A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 017921066 Device count 1 DM exempt false Premarket exempt false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07290115932508 Tower Guide ST PREMIA SPINE LTD NKB 2026-07-23 07290115935578 PER Trial 60 PREMIA SPINE LTD NKB 2026-07-22 07290115935691 PER Trial 50 PREMIA SPINE LTD NKB 2026-07-22 00840466901035 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901035 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901042 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901042 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901059 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901059 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901066 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901066 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901073 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901073 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901080 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901080 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901097 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901097 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901103 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901103 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901110 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901110 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901127 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901127 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901141 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901141 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901158 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901158 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901165 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901165 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901172 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21
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