GUDID EOBN270191S0

Radial Emission Fiber, core 550µm, clad 578µm, fiber OD 1300µm, white Tefzel Jacket with length marking, standard SMA 905 connector with knurl nut, black protection cap, extension sleeve red, black bend protection, distal conical tip with silica capillary dome, capillary OD 1800µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed, customized KardiVa Label

OBERON GmbH Fiber Technologies

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: EOBN270191S0
• NIH Device Record Key: fdfe1bc1-2a5d-45a0-aea2-121f09ac7aa0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Laser Surgery Fiber - DiLA’S® Radial Venous Probe
• Company DUNS: 312889060
• Company Name: OBERON GmbH Fiber Technologies
• 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: 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	EOBN270191S0 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-19
• Device Publish Date: 2024-06-11

Devices Manufactured by OBERON GmbH Fiber Technologies

• EOBN220105S0 - NA: 2024-08-01 Laser Surgery Fiber, core 600µm, clad 660µm, fiber OD 890µm, blue Tefzel Jacket, freestanding SMA 905 connector with knurl nu
• EOBN210180S0 - NA: 2024-07-25 Laser Surgery Fiber, core 365µm, clad 400µm, fiber OD 580µm, blue Tefzel Jacket, standard SMA 905 connector with knurl nut, b
• EOBN210181S0 - NA: 2024-07-25 Laser Surgery Fiber, core 365µm, clad 400µm, fiber OD 580µm, blue Tefzel Jacket, standard SMA 905 connector with knurl nut, b
• EOBN270190S0 - NA: 2024-06-19 Radial Emission Fiber, core 400µm, clad 420µm, fiber OD 950µm, white Tefzel Jacket with length marking, standard SMA 905 conn
• EOBN270191S0 - NA: 2024-06-19Radial Emission Fiber, core 550µm, clad 578µm, fiber OD 1300µm, white Tefzel Jacket with length marking, standard SMA 905 connector with knurl nut, black protection cap, extension sleeve red, black bend protection, distal conical tip with silica capillary dome, capillary OD 1800µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed, customized KardiVa Label
• EOBN270191S0 - NA: 2024-06-19 Radial Emission Fiber, core 550µm, clad 578µm, fiber OD 1300µm, white Tefzel Jacket with length marking, standard SMA 905 con
• EOBN270192S0 - NA: 2024-06-19 Radial Emission Fiber, core 550µm, clad 578µm, fiber OD 1300µm, white Tefzel Jacket, standard SMA 905 connector with knurl nu
• EOBN270518S0 - NA: 2024-06-19 Proctology - Hemorrhoid Fiber Probe, core 550µm, clad 578µm, fiber OD 1300µm, white Tefzel Jacket, standard SMA 905 connector
• 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