FMS 287535

GUDID 20886705000576

FMS Meniscus Cutter Shaver Blades 5.0mm

DEPUY MITEK, LLC

Arthroscopic shaver system blade, single-use

• Primary Device ID: 20886705000576
• NIH Device Record Key: 097b141f-fe88-435b-a5f7-5916215fe193
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FMS
• Version Model Number: 287535
• Catalog Number: 287535
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• 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
• 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 Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Pallet 2 Stacked
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705000579 [Primary]
GS1	20886705000576 [Package]; Contains: 10886705000579; Package: PACKAGE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954465

FDA Product Code

• HRX: ARTHROSCOPE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-07-04
• Device Publish Date: 2016-10-12

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• 30886705023060: FMS Fluid Management System Inflow Tubing (FMS VUE)
• 20886705017451: FMS Fluid Management System Outflow Tubing with One-way valve (FMS DUO Plus)
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• 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
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• 10886705023660: FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Wolf
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• 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
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• 20886705025449: FMS Round Burr Plus 5.0mm
• 20886705025432: FMS Round Tornado Burr Plus 4.0mm
• 20886705025425: FMS Round Burr Plus 4.0mm
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• 20886705025104: FMS XL ROUND BURR PLUS 5.0mm
• 20886705025098: FMS XL ROUND TORNADO BURR PLUS 4.0mm
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• 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
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