GUDID EOBN230031S0

Laser Surgery Fiber, core 320µm, clad 385µm, fiber OD 415µm, polyimide coating, standard SMA 905 connector with knurl nut, PVC protection cap, extension sleeve red engraved, black bend protection, Silicone tubing OD 2mm, distal flat tip, cleaved, 10cm freestanding fiber, NA 0.22, length 3m +/-0,2m, sterile EO, disposable, single packed,

OBERON GmbH Fiber Technologies

General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable

• Primary Device ID: EOBN230031S0
• NIH Device Record Key: d8ab4c82-e413-4c16-8bf4-ae5945a81746
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Dental Surgery 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	EOBN230031S0 [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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-18

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