Home GUDID 00856482008115 KLS MaxDriver 2
Primary DI 00856482008115
Brand KLS MaxDriver 2
Company PRO-DEX, INC.
Model KLS-SD-2000
Published 2022-03-29
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 GEY Motor, Surgical Instrument, Ac-Powered GXL Screwdriver, Skullplate HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEY Motor, Surgical Instrument, Ac-Powered General, Plastic Surgery 1 GXL Screwdriver, Skullplate Neurology 1 HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00856482008115 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 00856482008115 00856482008115 856482008115 0856482008115
GMDN Terms# Term, Definition table Term Definition Surgical power tool system handpiece, rotary, non-rechargeable battery-powered, reusable A hand-held device intended to provide rotation for a rotary endpiece instrument during surgical procedures performed on bones and tough tissues (e.g., cartilage, ligaments). It typically has the capacity to be used with a variety of rotary instruments (e.g., drill bits, reamers) and is not dedicated to a specific clinical procedure. It includes a built-in motor and an attachment for direct connection of an endpiece(s) [which is not included]. It is powered by a single-use sterile battery pack that normally will attach to, or is inserted into, the handpiece. The device may be cannulated to allow the use of a guidewire, and may be of the micro or macro design. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 849370358 Device count 1 Premarket exempt true Lot or batch true Serial number 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 00856482008122 BATTERY PACK, KLS-SD-2000, SINGLE KLS-BP2-001 2022-03-29 00860540000218 MatrixPro Sterilization Case Lid 60.000.011 2022-03-28 00856482008252 Pro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER) PDCMF-1000-1 2022-04-01 00856482008283 Battery Pack, Single Use, PDCMF, Tadiran PDCMF-BP-001 2022-04-01 00856482008016 KLS E-Coupling Adapter PDEC-1000-3 2022-03-29 00856482008207 Pro-Dex Surgical Driver PDSD-5000-1 2022-03-29 00856482008214 Pro-Dex Surgical Driver AO Collet PDSD-5000-2 2022-03-29 00856482008290 Pro-Dex Surgical Driver Custom Collet PDSD-5000-5 2022-03-29 00860540000256 ProDriver Battery Pack, Single PDBP-001-2 2022-03-29 00862377000119 MatrixPRO Driver Battery Pack, Sterile 05.000.021S 2022-03-23 00856482008009 Atlas Pro Driver Battery Pack, Sterile APD-BP-001S-1 2020-03-13 00860540000201 MatrixPro sterilization case 60.000.010 2020-03-27 00856482008108 Matrix Pro II Graphics case 60.000.015 2020-03-11 00856482008436 Zimmer Biomet Atlas Pro Driver APD-1000-4 2023-06-09 00856482008269 MatrixPRO II Handpiece Loaner 05.000.030LN 2022-04-01 00860540000225 MatrixPRO Driver Loaner 05.000.020LN 2022-04-01 00856482008245 Pro-Dex Surgical Driver Medicon PDSD-5000-6 2022-03-29 00862377000188 KLS Martin Surgical Driver, Non-Torque Limiting KLS-SD-1000-NTL 2022-03-29 00862377000133 KLS MARTIN SURGICAL DRIVER KLS-SD-1000 2022-03-28 00862377000164 Atlas Pro Driver APD-1000-1 2022-03-28
Other Devices Sharing Product Codes#