Typenex Surgical Single Use Optical Fiber

GUDID B050MF365ST2051

Single Use Sterile 365 Micrometer Optical Fiber RFID

TYPENEX MEDICAL LLC

Laser lithotripsy system

• Primary Device ID: B050MF365ST2051
• NIH Device Record Key: 29586b83-dc14-4f05-b16b-edfea431df8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Typenex Surgical Single Use Optical Fiber
• Version Model Number: MF365ST205
• 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: 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: 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	B050MF365ST2050 [Primary]
HIBCC	B050MF365ST2051 [Package]; Contains: B050MF365ST2050; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131473

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-26

On-Brand Devices [Typenex Surgical Single Use Optical Fiber ]

• B050MF800ST2051: Single Use Sterile 800 Micrometer Surgical Optical Fiber RFID
• B050MF550ST2051: Single Use Sterile 550 Micrometer Optical Fiber RFID
• B050MF365ST2051: Single Use Sterile 365 Micrometer Optical Fiber RFID
• B050MF272ST2051: Single Use Sterile 272 Micrometer Surgical Optical Fiber RFID
• B050MF200ST2051: Single Use Sterile 200 Micrometer Surgical Optical Fiber RFID