GUDID EOBN230052N0

OBERON GmbH Fiber Technologies

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• Primary Device ID: EOBN230052N0
• NIH Device Record Key: 63376f54-b29b-4037-b1e6-8e186be52482
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Laser Surgery Fiber - Dental Bare Fiber 320µm
• Company DUNS: 312889060
• Company Name: OBERON GmbH Fiber Technologies
• 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: 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	EOBN230052N0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140470

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-25
• Device Publish Date: 2019-01-24

Devices Manufactured by OBERON GmbH Fiber Technologies

• EOBN220138S0 - NA: 2024-02-01 Laser Surgery Fiber, core 600µm, clad 660µm, fiber OD 890µm, blue Tefzel Jacket, freestanding SMA 905 connector with knurl nu
• EOBN210135S0 - NA: 2022-03-25 Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connect
• EOBN210136S0 - NA: 2022-03-25 Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connect
• EOBN210137S0 - NA: 2022-03-25 Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, freestanding SM
• EOBN210138S0 - NA: 2022-03-25 Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, freestanding SM
• EOBN270122S0 - NA: 2021-12-31 Radial Emission Fiber, core 400µm, clad 420µm, fiber OD 900µm, white Tefzel Jacket with length marking, SMA 905 connector, bl
• EOBN270123S0 - NA: 2021-12-31 Radial Emission Fiber, core 550µm, clad 578µm, fiber OD 1300µm, white Tefzel Jacket with length marking, SMA 905 connector, b
• EOBN210167S0 - NA: 2021-08-24 Laser Surgery Fiber, core 600µm, clad 660µm, fiber OD 870µm, blue Tefzel Jacket, SMA 905 holmium connector with knurl nut, bl