MaxiFlex Holmium Laser Fiber

GUDID B324MF400BHT0

365 micron Holmium Laser Fiber with SMA 905 connector for Trimedyne lasers.

MAXIFLEX, LLC

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: B324MF400BHT0
• NIH Device Record Key: 985bcecc-1f2b-40e7-a2e7-6be1c80d6af1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MaxiFlex Holmium Laser Fiber
• Version Model Number: MF 400BH T
• Company DUNS: 198887072
• Company Name: MAXIFLEX, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• Manufacturing Date: true
• 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

Device Dimensions

• Outer Diameter: 550 Micrometer
• Outer Diameter: 550 Micrometer
• Outer Diameter: 550 Micrometer
• Outer Diameter: 550 Micrometer
• Outer Diameter: 550 Micrometer
• Outer Diameter: 550 Micrometer
• Outer Diameter: 550 Micrometer
• Outer Diameter: 550 Micrometer
• Outer Diameter: 550 Micrometer
• Outer Diameter: 550 Micrometer
• Outer Diameter: 550 Micrometer
• Outer Diameter: 550 Micrometer
• Outer Diameter: 550 Micrometer
• Outer Diameter: 550 Micrometer
• Outer Diameter: 550 Micrometer
• Outer Diameter: 550 Micrometer

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B324MF400BHT0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013300

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[B324MF400BHT0]

Ethylene Oxide

[B324MF400BHT0]

Ethylene Oxide

[B324MF400BHT0]

Ethylene Oxide

[B324MF400BHT0]

Ethylene Oxide

[B324MF400BHT0]

Ethylene Oxide

[B324MF400BHT0]

Ethylene Oxide

[B324MF400BHT0]

Ethylene Oxide

[B324MF400BHT0]

Ethylene Oxide

[B324MF400BHT0]

Ethylene Oxide

[B324MF400BHT0]

Ethylene Oxide

[B324MF400BHT0]

Ethylene Oxide

[B324MF400BHT0]

Ethylene Oxide

[B324MF400BHT0]

Ethylene Oxide

[B324MF400BHT0]

Ethylene Oxide

[B324MF400BHT0]

Ethylene Oxide

[B324MF400BHT0]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [MaxiFlex Holmium Laser Fiber ]

• B324MF600BHTR0: 550 micron Holmium Laser Fiber with SMA 905 connector for Trimedyne lasers (reusable).
• B324MF600BHT0: 550 micron Holmium Laser Fiber with SMA 905 connector for Trimedyne lasers.
• B324MF600BHR0: 550 micron Holmium Laser Fiber with SMA 905 connector for Lumenis lasers (reusable).
• B324MF600BHNR0: 550 micron Holmium Laser Fiber with SMA 905 connector for Newstar lasers (reusable).
• B324MF600BHN0: 550 micron Holmium Laser Fiber with SMA 905 connector for Newstar lasers.
• B324MF600BHDR0: 550 micron Holmium Laser Fiber with SMA 905 connector for Dornier lasers (reusable).
• B324MF600BHD0: 550 micron Holmium Laser Fiber with SMA 905 connector for Dornier lasers.
• B324MF600BHCR0: 550 micron Holmium Laser Fiber with SMA 905 connector for Convergent lasers (reusable).
• B324MF600BHC0: 550 micron Holmium Laser Fiber with SMA 905 connector for Convergent lasers.
• B324MF600BH0: 550 micron Holmium Laser Fiber with SMA 905 connector for Lumenis lasers.
• B324MF400BHTR0: 365 micron Holmium Laser Fiber with SMA 905 connector for Trimedyne lasers (reusable).
• B324MF400BHT0: 365 micron Holmium Laser Fiber with SMA 905 connector for Trimedyne lasers.
• B324MF400BHR0: 365 micron Holmium Laser Fiber with SMA 905 connector for Lumenis lasers (reusable).
• B324MF400BHNR0: 365 micron Holmium Laser Fiber with SMA 905 connector for Newstar lasers (reusable).
• B324MF400BHN0: 365 micron Holmium Laser Fiber with SMA 905 connector for Newstar lasers.
• B324MF400BHDR0: 365 micron Holmium Laser Fiber with SMA 905 connector for Dornier lasers (reusable).
• B324MF400BHD0: 365 micron Holmium Laser Fiber with SMA 905 connector for Dornier lasers.
• B324MF400BHCR0: 365 micron Holmium Laser Fiber with SMA 905 connector for Convergent lasers (reusable).
• B324MF400BHC0: 365 micron Holmium Laser Fiber with SMA 905 connector for Convergent lasers.
• B324MF400BH0: 365 micron Holmium Laser Fiber with SMA 905 connector for Lumenis lasers.
• B324MF200BHHPXTR0: 272 micron Holmium Laser Fiber with SMA 905 connector for Trimedyne lasers (reusable).
• B324MF200BHHPXT0: 272 micron Holmium Laser Fiber with SMA 905 connector for Trimedyne lasers.
• B324MF200BHHPXR0: 272 micron Holmium Laser Fiber with SMA 905 connector for Lumenis lasers (reusable).
• B324MF200BHHPXNR0: 272 micron Holmium Laser Fiber with SMA 905 connector for Newstar lasers (reusable).
• B324MF200BHHPXN0: 272 micron Holmium Laser Fiber with SMA 905 connector for Newstar lasers.
• B324MF200BHHPXDR0: 272 micron Holmium Laser Fiber with SMA 905 connector for Dornier lasers (reusable).
• B324MF200BHHPXD0: 272 micron Holmium Laser Fiber with SMA 905 connector for Dornier lasers.
• B324MF200BHHPXCR0: 272 micron Holmium Laser Fiber with SMA 905 connector for Convergent lasers (reusable).
• B324MF200BHHPXC0: 272 micron Holmium Laser Fiber with SMA 905 connector for Convergent lasers.
• B324MF200BHHPX0: 272 micron Holmium Laser Fiber with SMA 905 connector for Lumenis lasers.
• B324MF1000BHTR0: 940 micron Holmium Laser Fiber with SMA 905 connector for Trimedyne lasers (reusable).
• B324MF1000BHT0: 940 micron Holmium Laser Fiber with SMA 905 connector for Trimedyne lasers.
• B324MF1000BHR0: 940 micron Holmium Laser Fiber with SMA 905 connector for Lumenis lasers (reusable).
• B324MF1000BHNR0: 940 micron Holmium Laser Fiber with SMA 905 connector for Newstar lasers (reusable).
• B324MF1000BHN0: 940 micron Holmium Laser Fiber with SMA 905 connector for Newstar lasers.
• B324MF1000BHDR0: 940 micron Holmium Laser Fiber with SMA 905 connector for Dornier lasers (reusable).
• B324MF1000BHD0: 940 micron Holmium Laser Fiber with SMA 905 connector for Dornier lasers.
• B324MF1000BHCR0: 940 micron Holmium Laser Fiber with SMA 905 connector for Convergent lasers (reusable).
• B324MF1000BHC0: 940 micron Holmium Laser Fiber with SMA 905 connector for Convergent lasers.
• B324MF1000BH0: 940 micron Holmium Laser Fiber with SMA 905 connector for Lumenis lasers.