Home GUDID 00810072351074 Vortex
Primary DI 00810072351074
Brand Vortex
Company Cole Instruments Inc
Model Vortex
Catalog number 920.000
Device description Vortex.Sterilize handpiece nosecone before first use and before each use.
Published 2021-02-04
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name MOQ Battery, Replacement, Rechargeable
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MOQ Battery, Replacement, Rechargeable General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810072351074 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 00810072351074 00810072351074 810072351074 0810072351074
GMDN Terms# Term, Definition table Term Definition Surgical power tool system handpiece, wire-driving, rechargeable battery-powered A battery-powered, drill-like, machine intended to be used for the sole purpose of driving in orthopaedic bone wires, e.g., Steinmann pins, Kirschner wires or K-Wires (thin needle-like pins of different widths that are pointed for self-drilling), into bone for the restoration of bones. This device will typically have a special gripping collet for rapid repositioning of the hold on the wire as it is fed into the bone. A rechargeable battery pack is attached to this device to provide the low-voltage electrical power. This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 30 Percent (%) Relative Humidity 70 Percent (%) Relative Humidity Storage Environment Temperature -10 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 078573265 Device count 1 Premarket exempt true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810072350503 0.80 mm window punch, 5 pack IHTI-0.80-2S-094-WP punch 109.080 2021-02-04 00810072350510 0.80 mm window punch, 10 pack IHTI-0.80-2S-094-WP punch 109.080 2021-02-04 00810072351197 Graft Slivering Board Graft Slivering Board 621.000 2022-12-08 00810072351005 mini Powered Cole Isolation Device mPCID 910.000 2021-02-04 00810072351159 Graft Storage Plate Graft Storage Plate 360.100 2022-12-08 00810072350046 0.80 mm regular punch, 5 pack CI-0.80-3C-094 punch 102.080 2021-02-04 00810072350053 0.80 mm regular punch, 10 pack CI-0.80-3C-094 punch 102.080 2021-02-04 00810072350060 0.85 mm regular punch, 5 pack CI-0.85-3C-094 punch 102.085 2021-02-04 00810072350077 0.85 mm regular punch, 10 pack CI-0.85-3C-094 punch 102.085 2021-02-04 00810072350084 0.90 mm regular punch, 5 pack CI-0.90-3C-094 punch 102.090 2021-02-04 00810072350091 0.90 mm regular punch, 10 pack CI-0.90-3C-094 punch 102.090 2021-02-04 00810072350107 0.95 mm regular punch, 5 pack CI-0.95-3C-094 punch 102.095 2021-02-04 00810072350114 0.95 mm regular punch, 10 pack CI-0.95-3C-094 punch 102.095 2021-02-04 00810072350121 1.00 mm regular punch, 5 pack CI-1.00-3C-094 punch 102.100 2021-02-04 00810072350138 1.00 mm regular punch, 10 pack CI-1.00-3C-094 punch 102.100 2021-02-04 00810072350145 1.05 mm regular punch, 5 pack CI-1.05-3C-094 punch 102.105 2021-02-04 00810072350152 1.05 mm regular punch, 10 pack CI-1.05-3C-094 punch 102.105 2021-02-04 00810072350169 1.10 mm regular punch, 5 pack CI-1.10-3C-094 punch 102.110 2021-02-04 00810072350176 1.10 mm regular punch, 10 pack CI-1.10-3C-094 punch 102.110 2021-02-04 00810072350220 0.90 mm non-coated titanium punch, 5 pack CI-0.90-2T1-094 punch 103.090 2021-02-04
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