Home GUDID 00847538001051 Quick-Coupling Handle for Flexible Osteotomes
Primary DI 00847538001051
Brand Quick-Coupling Handle for Flexible Osteotomes
Company SYMMETRY MEDICAL INC.
Model 10-020-000
Catalog number 2709-04-001
Device description Quick-Coupling Handle for Flexible Osteotomes
Published 2022-05-10
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information 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 00847538001051 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 00847538001051 00847538001051 847538001051 0847538001051
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 079881212 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00847538007787 Component Impactor 10-016-400-1500 2011-03-037 2022-05-17 00847538005479 Patella Caliper 802-01-112 2025-12-10 00847538007930 Bone Hook - Small 10-257-000 803-61-025 2025-10-20 00847538008654 HP Extraction Standard Removal Case 87-1008 2011-03-048 2023-11-28 00847538015256 Flexible Osteotome System with Radel Case 30-005-000 2709-04-000; 30-005-000-1500 2023-07-17 00847538019179 Femoral Tray 30-037-400 2709-01-000; 30-037-400-1500 2023-07-17 00817766026423 GLOBAL UNITE™ Short Stem Instrumentation 223600211 2021-09-01 00847538010558 Tuning Fork 12-070-000 2011-03-030 2022-05-17 00847538010565 MBT Tray/Sleeve Separator 12-071-400 2011-03-053 2022-05-17 00847538010572 Sleeve Removal Tool 12-072-000 2011-03-031 2022-05-17 00847538005431 Extraction Screw, 8 MM 12-010-000-1500 2011-03-042 2022-05-13 00847538010527 Head Extractor 12-063-000 2500-00-779 2022-05-13 00847538010534 Forked Stem Extractor Wide 12-065-000 2500-00-781 2022-05-13 00847538010541 Forked Stem Extractor Narrow 12-067-000 2500-00-780 2022-05-13 00847538015751 Adapter Slaphammer to Locking Pliers 12-053-000-1500 2011-03-046 2022-05-13 00847538015768 Stem Trial Remover Slaphammer adapter 12-054-000-1500 2011-03-047 2022-05-13 00847538015775 Tibial Component Extractor 74-591-000-1500 2011-03-045 2022-05-13 00847538007916 Head Removal Fork 10-246-400 2500-00-776 2022-05-12 00847538001471 T-Bar Stem Extractor 10-062-000 2709-05-003;00-9986-040-12 2022-05-11 00847538010473 Driver Shaft w/Slaphammer w/Hudson Connector 12-048-000 2709-05-001 2022-05-11
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