Home GUDID B0842002700000 Keos Lumbar Instrument
Primary DI B0842002700000
Brand Keos Lumbar Instrument
Company KEOS
Model Insertion Handle, Clamp
Catalog number 200-27-0000
Published 2023-01-30
Public version status Update
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 LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B0842002700000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Surgical implant/trial-implant/sizer holder, reusable A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 080551837 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 true 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 B0842000200000 Keos Lumbar Case/Caddy Implant Case, Lumbar IBFD System, w/ Lid 200-02-0000 2023-01-30 B0842000200100 Keos Lumbar Case/Caddy Instrument Case, Lumbar IBFD System, w/ Lid 200-02-0010 2023-01-30 B0842000200210 Keos Lumbar Case/Caddy Lid, Lumbar IBFD System 200-02-0021 2023-01-30 B0842000201000 Keos Lumbar Case/Caddy Caddy Assy, 23L x 8W, Straight, PEEK 200-02-0100 2023-01-30 B0842000201010 Keos Lumbar Case/Caddy Caddy Assy, 23L x 10W, Straight, PEEK 200-02-0101 2023-01-30 B0842000201020 Keos Lumbar Case/Caddy Caddy Assy, 28L x 10W, Straight, PEEK 200-02-0102 2023-01-30 B0842000201030 Keos Lumbar Case/Caddy Caddy Assy, 28L x 10W, Curved, PEEK 200-02-0103 2023-01-30 B0842000201040 Keos Lumbar Case/Caddy Caddy Assy, 23L x 8W, Straight, PEEK HA-Enhanced 200-02-0104 2023-01-30 B0842000201050 Keos Lumbar Case/Caddy Caddy Assy, 23L x 10W, Straight, PEEK HA-Enhanced 200-02-0105 2023-01-30 B0842000201060 Keos Lumbar Case/Caddy Caddy Assy, 28L x 10W, Straight, PEEK HA-Enhanced 200-02-0106 2023-01-30 B0842000201070 Keos Lumbar Case/Caddy Caddy Assy, 28L x 10W, Curved, PEEK HA-Enhanced 200-02-0107 2023-01-30 B0842000201510 Keos Lumbar Case/Caddy Caddy Lid, PEEK 200-02-0151 2023-01-30 B0842000201530 Keos Lumbar Case/Caddy Caddy Lid, PEEK HA-Enhanced 200-02-0153 2023-01-30 B0842000202000 Keos Lumbar Case/Caddy Instrument Case, Limited Release MPE, w/ Lid 200-02-0200 2023-01-30 B0842000203000 Keos Lumbar Case/Caddy Auxiliary Case, w/ Lid 200-02-0300 2023-01-30 B0842002400000 Keos Lumbar Instrument T-Handle, QC, 1/4" Square Adapter 200-24-0000 2023-01-30 B0842002600000 Keos Lumbar Instrument Insertion Handle, Threaded 200-26-0000 2023-01-30 B0842002600100 Keos Lumbar Instrument Insertion Rod, Threaded 200-26-0010 2023-01-30 B0842002700020 Keos Lumbar Instrument Attachment Knob, Insertion Handle, Clamp 200-27-0002 2023-01-30 B0842002700100 Keos Lumbar Instrument Insertion Fork, Insertion Handle, Clamp 200-27-0010 2023-01-30
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