FMS 283812

GUDID 10886705030743

FMS Fluid Management System Tornado Micro II Hand Controlled Shaver Handpiece Shaver handpiece with hand control

Medos International Sàrl

Arthroscopic shaver system, line-powered Arthroscopic shaver system, electrically-powered Arthroscopic shaver system, electrically-powered Arthroscopic shaver system, electrically-powered Arthroscopic shaver system, electrically-powered Arthroscopic shaver system, electrically-powered Arthroscopic shaver system, electrically-powered Arthroscopic shaver system, electrically-powered Arthroscopic shaver system, electrically-powered

• Primary Device ID: 10886705030743
• NIH Device Record Key: 628e7ce9-cd2d-4630-8bad-d73304154f67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FMS
• Version Model Number: 283812
• Catalog Number: 283812
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• 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
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705030743 [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

[10886705030743]

Moist Heat or Steam Sterilization

[10886705030743]

Moist Heat or Steam Sterilization

[10886705030743]

Moist Heat or Steam Sterilization

[10886705030743]

Moist Heat or Steam Sterilization

[10886705030743]

Moist Heat or Steam Sterilization

[10886705030743]

Moist Heat or Steam Sterilization

[10886705030743]

Moist Heat or Steam Sterilization

[10886705030743]

Moist Heat or Steam Sterilization

[10886705030743]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-29
• Device Publish Date: 2020-06-19

On-Brand Devices [FMS]

• 20886705000781: FMS 3.0mm Mini Round Tornado Burr Plus
• 20886705000019: FMS 2.0mm Mini Round Tornado Burr Plus
• 10886705030743: FMS Fluid Management System Tornado Micro II Hand Controlled Shaver Handpiece Shaver handpiece w
• 10886705030736: FMS Fluid Management System Tornado Micro II No-Button Shaver Handpiece Shaver handpiece without
• 10886705017010: FMS 5-Way Foot Pedal
• 10886705016990: FMS Remote Control
• 10886705020485: FMS VUE Fluid Management System FMS CONNECT Interface Cable
• 20886705027276: FMS Mini Ultra-Aggressive Blade Plus 3.5mm
• 20886705027269: FMS Mini Aggressive Blade Plus 3.5mm
• 20886705027252: FMS Mini Full Radius Blade Plus 3.5mm
• 20886705027245: FMS Ultra-Aggressive Blade Plus 3.5mm
• 20886705027238: FMS Aggressive Blade Plus 3.5mm
• 20886705027221: FMS Full Radius Blade Plus 3.5mm
• 20886705027191: FMS Mini Ultra-Aggressive Blade Plus 2.7mm
• 20886705027184: FMS Mini Full Radius Blade Plus 2.7mm
• 20886705025975: FMS XL CURVED MULTI BLADE PLUS 4.2MM
• 20886705025968: FMS CURVED MULTI BLADE PLUS 4.2MM
• 20886705025951: FMS XL CURVED FULL RADIUS BLADE PLUS 4.2MM
• 20886705025944: FMS XL CURVED AGGRESSIVE BLADE PLUS 4.2MM
• 20886705025937: FMS CURVED FULL RADIUS BLADE PLUS 4.2MM
• 20886705025920: FMS CURVED AGGRESSIVE BLADE PLUS 4.2MM
• 20886705025913: FMS XL CURVED ULTRA-AGGRESSIVE BLADE PLUS 4.2MM
• 20886705025906: FMS CURVED ULTRA-AGGRESSIVE BLADE PLUS 4.2MM