OBERON GmbH Fiber Technologies

Address:Ludwig-Witthoeft-Strasse 14,Wildau Brandenburg,DE

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Powered Laser Surgical Instrument (GEX) (9)

Premarket Exempt

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NA - EOBN270029S0 Catalog Number :

Device Description : Corona 360 Fiber, core 550µm, clad 578µm, fiber OD 1400µm, white Vestodur Jacket Corona 360 Fiber, core 550µm, clad 578µm, fiber OD 1400µm, white Vestodur Jacket with length marking, customized connector, white 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

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN270055S0 Catalog Number :

Device Description : Radial Emission Fiber, core 400µm, clad 420µm, fiber OD 950µm, white Vestodur Ja Radial Emission Fiber, core 400µm, clad 420µm, fiber OD 950µm, white Vestodur Jacket with length marking, standard SMA905 connector with knurl nut, PVC protection cap, extension sleeve red engraved, black bend protection, LUER adapter, distal conical tip with silica capillary dome, capillary OD 1000µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN270082S0 Catalog Number :

Device Description : Corona 360 Radial Fiber, core 550µm, clad 578µm, fiber OD 1300µm, white Tefzel J Corona 360 Radial Fiber, core 550µm, clad 578µm, fiber OD 1300µm, white Tefzel Jacket with length marking, customized connector, white 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

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN270117S0 Catalog Number :

Device Description : Radial Emission Fiber with Stopper, core 400µm, clad 420µm, fiber OD 900µm, whit Radial Emission Fiber with Stopper, core 400µm, clad 420µm, fiber OD 900µm, white Tefzel Jacket, SMA 905 connector, PVC protection cap, RFID extension sleeve red, black bend protection, stopper 466mm from distal end, distal conical tip with silica capillary dome 1000µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN270118S0 Catalog Number :

Device Description : Radial Emission Fiber Vein, core 400µm, clad 420µm, fiber OD 900µm, white Tefzel Radial Emission Fiber Vein, core 400µm, clad 420µm, fiber OD 900µm, white Tefzel Jacket with length marking, SMA 905 connector, PVC protection cap, RFID extension sleeve red, black bend protection, distal conical tip with silica capillary dome 1000µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN270119S0 Catalog Number :

Device Description : Radial Emission Fiber with Stopper, core 550µm, clad 578µm, fiber OD 1400µm, whi Radial Emission Fiber with Stopper, core 550µm, clad 578µm, fiber OD 1400µm, white Tefzel Jacket, SMA 905 connector, PVC protection cap, RFID extension sleeve red, black bend protection, stopper 466mm from distal end, distal conical tip with silica capillary dome 1800µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN270120S0 Catalog Number :

Device Description : Radial Emission Fiber Vein, core 550µm, clad 578µm, fiber OD 1400µm, white Tefze Radial Emission Fiber Vein, core 550µm, clad 578µm, fiber OD 1400µm, white Tefzel Jacket with length marking, SMA 905 connector, PVC protection cap, RFID extension sleeve red, black bend protection, distal conical tip with silica capillary dome 1800µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN270122S0 Catalog Number :

Device Description : Radial Emission Fiber, core 400µm, clad 420µm, fiber OD 900µm, white Tefzel Jack Radial Emission Fiber, core 400µm, clad 420µm, fiber OD 900µm, white Tefzel Jacket with length marking, SMA 905 connector, black protection cap, black bend protection, distal conical tip with silica capillary dome 1000µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN270123S0 Catalog Number :

Device Description : Radial Emission Fiber, core 550µm, clad 578µm, fiber OD 1300µm, white Tefzel Jac Radial Emission Fiber, core 550µm, clad 578µm, fiber OD 1300µm, white Tefzel Jacket with length marking, SMA 905 connector, black protection cap, black bend protection, distal conical tip with silica capillary dome 1800µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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