FMS 283512

GUDID 10886705016938

FMS Tornado Micro Shaver Handpiece

DEPUY MITEK, LLC

Arthroscopic shaver system, electrically-powered

• Primary Device ID: 10886705016938
• NIH Device Record Key: bbabf0c2-df0f-40dd-ad88-9184bb86fe91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FMS
• Version Model Number: 283512
• Catalog Number: 283512
• Company DUNS: 190572854
• Company Name: DEPUY MITEK, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705016938 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041824

FDA Product Code

• HRX: ARTHROSCOPE

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10886705016938]

Moist Heat or Steam Sterilization

[10886705016938]

Moist Heat or Steam Sterilization

[10886705016938]

Moist Heat or Steam Sterilization

[10886705016938]

Moist Heat or Steam Sterilization

[10886705016938]

Moist Heat or Steam Sterilization

[10886705016938]

Moist Heat or Steam Sterilization

[10886705016938]

Moist Heat or Steam Sterilization

[10886705016938]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-07-04
• Device Publish Date: 2015-09-01

On-Brand Devices [FMS]

• 20886705016065: FMS Waste Collection Bag
• 20886705023230: FMS Fluid Management System Outflow Tubing with One-Way valve (FMS VUE or FMS DUO Plus)
• 30886705023220: FMS Fluid Management System Outflow Tubing without One-Way valve (FMS VUE or FMS DUO Plus)
• 30886705023060: FMS Fluid Management System Inflow Tubing (FMS VUE)
• 20886705017451: FMS Fluid Management System Outflow Tubing with One-way valve (FMS DUO Plus)
• 20886705017437: FMS Patient Set Without One-Way Valve Arthroscopy Tubing
• 10886705016358: FMS Obturator for Cannulas 281580
• 20886705015907: FMS Fluid Management System Intermediary Tubing with One-way valve
• 20886705015853: FMS Gravity Tubing
• 20886705015761: FMS Fluid Management System Intermediary Tubing Without One-Way valve
• 10886705016327: fms Obturator for Cannulas 281572
• 10886705023769: FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow-Linvatec
• 10886705023752: FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow Sheath-Wolf
• 10886705023745: FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow Sheath-Stryker
• 10886705023738: FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow Sheath-Storz
• 10886705023721: FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow Sheath-Smith & Nephew
• 10886705023714: FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow Sheath-Olympus
• 10886705023660: FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Wolf
• 10886705023653: FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Stryker
• 10886705023646: FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Storz
• 10886705023639: FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Smith & Nephew
• 10886705023622: FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Olympus
• 10886705023615: FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Linvatec
• 10886705018369: FMS Remote Control For FMS SOLO
• 10886705017256: FMS 4 Way Foot Pedal For FMS DUO Plus
• 10886705017249: FMS 2 Way Foot Pedal for FMS DUO PLUS
• 10886705017232: FMS 1 Way Foot Pedal for FMS SOLO
• 10886705016341: fms Trocar for Cannulas 281580
• 10886705016440: FMS Hand Control Interface To Arthrex Adapteur Power System II
• 20886705016331: FMS Fluid Management System 4.5mm FMS Outflow Cannula
• 20886705016317: FMS Fluid Management System 2.5mm FMS Outflow Cannula
• 10886705020478: FMS Fluid Management System FMS CONNECT Interface Cable - DUO PLUS/SOLO
• 20886705025494: FMS Round Tornado Burr Plus 5.0mm
• 20886705025449: FMS Round Burr Plus 5.0mm
• 20886705025432: FMS Round Tornado Burr Plus 4.0mm
• 20886705025425: FMS Round Burr Plus 4.0mm
• 20886705025111: FMS XL ROUND TORNADO BURR PLUS 5.0mm
• 20886705025104: FMS XL ROUND BURR PLUS 5.0mm
• 20886705025098: FMS XL ROUND TORNADO BURR PLUS 4.0mm
• 20886705025081: FMS XL ROUND BURR PLUS 4.0mm
• 20886705025067: FMS XL ULTRA-AGGRESSIVE RADIUS BLADE PLUS 4.2mm
• 20886705025050: FMS XL AGGRESSIVE BLADE PLUS 4.2mm
• 20886705025043: FMS XL FULL RADIUS BLADE PLUS 4.2mm
• 20886705025036: FMS XL MULTI BLADE PLUS 4.2mm
• 20886705023094: FMS BARREL BURR PLUS 5.0mm FOR USE with FMS DUO+ System
• 20886705023087: FMS BARREL BURR PLUS 5.0mm
• 20886705022226: FMS ULTRA-AGGRESSIVE BLADE PLUS 4.0mm
• 20886705022103: FMS BARREL TORNADO BURR PLUS 5.0mm
• 20886705022097: FMS MULTI BLADE PLUS 5.0mm
• 20886705022080: FMS ULTRA-AGGRESSIVE BLADE PLUS 5.0mm