Home GUDID M97022003500000 DynaNail
Primary DI M97022003500000
Brand DynaNail
Company Medshape, Inc.
Model 2200-35-0000
Device description Outer Body Removal Tool, DynaNail
Published 2025-10-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true 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 M97022003500000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone-fragment manipulator, single-use A hand-held manual surgical instrument designed to help position a fractured fragment of bone to achieve proper alignment (reduction). It is typically a long, thin, rigid rod made of high-grade stainless steel with a self-drilling/self-tapping screw thread at the distal end and a connector at the proximal end to attach an appropriate handle. The device is usually inserted transcutaneously to the fractured section of bone (e.g., through the skin and into a craniofacial fracture) and removed after positioning and fixation of the fracture. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 601306413 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860011177814 Wright-Out Hip Stem Extractor Guide Block and Osteotome Blade Kit MAP MEDICAL SOLUTIONS, LLC LXH 2026-07-06 00860011177838 Wright-Out Hip Stem Extractor Slide Hammer MAP MEDICAL SOLUTIONS, LLC LXH 2026-07-06 00860011177845 Wright-Out Hip Stem Extractor Osteotome Handle MAP MEDICAL SOLUTIONS, LLC LXH 2026-07-06 00860011177852 Wright-Out Hip Stem Extractor 5/64" T-Handle Hex Key MAP MEDICAL SOLUTIONS, LLC LXH 2026-07-06 00860011177869 Wright-Out Hip Stem Extractor 10mm T-Handle Socket Wrench MAP MEDICAL SOLUTIONS, LLC LXH 2026-07-06 03770019503416 Drill - Screw D.3,5mm-L.18 SC MEDICA LXH 2026-07-03 03770019503867 Cannulated Screwdriver tip for screw D3,5mm-L.16 SC MEDICA LXH 2026-07-03 00196449010196 Anatomic Access LLIF Tyber Medical, LLC LXH 2026-06-09 00196449010288 Anatomic Access LLIF Tyber Medical, LLC LXH 2026-06-09 00196449035243 Anatomic Access LLIF Tyber Medical, LLC LXH 2026-06-09 00196449035250 Anatomic Access LLIF Tyber Medical, LLC LXH 2026-06-09 00196449035267 Anatomic Access LLIF Tyber Medical, LLC LXH 2026-06-09 00196449035281 Anatomic Access LLIF Tyber Medical, LLC LXH 2026-06-09 00196449035298 Anatomic Access LLIF Tyber Medical, LLC LXH 2026-06-09 00196449035304 Anatomic Access LLIF Tyber Medical, LLC LXH 2026-06-09 00196449035311 Anatomic Access LLIF Tyber Medical, LLC LXH 2026-06-09 00196449035328 Anatomic Access LLIF Tyber Medical, LLC LXH 2026-06-09 00196449035335 Anatomic Access LLIF Tyber Medical, LLC LXH 2026-06-09 00196449035366 Anatomic Access LLIF Tyber Medical, LLC LXH 2026-06-09 00196449035380 Anatomic Access LLIF Tyber Medical, LLC LXH 2026-06-09 00196449035397 Anatomic Access LLIF Tyber Medical, LLC LXH 2026-06-09 00196449035441 Anatomic Access LLIF Tyber Medical, LLC LXH 2026-06-09 00196449035465 Anatomic Access LLIF Tyber Medical, LLC LXH 2026-06-09 00196449035472 Anatomic Access LLIF Tyber Medical, LLC LXH 2026-06-09 00810094692698 Modular Frog Eyes TOTAL JOINT ORTHOPEDICS, INC. LXH 2026-06-09 00810094692704 Distal Femoral Cut Block Connector TOTAL JOINT ORTHOPEDICS, INC. LXH 2026-06-09 00810094692933 Magnet Spacer, 5mm TOTAL JOINT ORTHOPEDICS, INC. LXH 2026-06-09 04052536123728 mambo Ulrich GmbH & Co. KG LXH 2026-06-09 08809945870578 BENCOX Corentec Co., Ltd LXH 2026-06-09 04052536085668 neon3 Ulrich GmbH & Co. KG LXH 2026-06-08