Typenex Surgical Reusable Optical Fiber

GUDID B050MF365RST2051

Reusable 10x, Sterile 365 Micrometer Surgical Optical Fiber RFID

TYPENEX MEDICAL LLC

Laser lithotripsy system

• Primary Device ID: B050MF365RST2051
• NIH Device Record Key: ecac2de7-2021-4cd3-b49d-5ad07d7d6c15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Typenex Surgical Reusable Optical Fiber
• Version Model Number: MF365RST205
• Company DUNS: 600850213
• Company Name: TYPENEX MEDICAL 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: 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: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com
• Phone: 312-888-4064
• Email: mchoquette@typenex.com

Device Dimensions

• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B050MF365RST2050 [Primary]
HIBCC	B050MF365RST2051 [Package]; Contains: B050MF365RST2050; Package: Outer Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160513

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[B050MF365RST2051]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-06

On-Brand Devices [Typenex Surgical Reusable Optical Fiber ]

• B050MF800RST2051: Reusable 10x, Sterile 800 Micrometer Surgical Optical Fiber RFID
• B050MF550RST2051: Reusable 10x, Sterile 550 Micrometer Surgical Optical Fiber RFID
• B050MF365RST2051: Reusable 10x, Sterile 365 Micrometer Surgical Optical Fiber RFID
• B050MF272RST2051: Reusable 10x, Sterile 272 Micrometer Surgical Optical Fiber RFID
• B050MF200RST2051: Reusable 10x, Sterile 200 Micrometer Surgical Optical Fiber RFID