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) (10)

Premarket Exempt

Clear

NA - EOBN210136S0 Catalog Number :

Device Description : Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420 Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, black protection cap, extension sleeve silver, black PVC protection tube OD 1,5mm over 3m+/-0,1m on the proximal side, fiber stop yellow 235mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 10m +/-0,05m, sterile EO, disposable, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN210137S0 Catalog Number :

Device Description : Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420 Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, freestanding SMA 905, black protection cap, extension sleeve silver, black PVC protection tube OD 1,5mm over 3m+/-0,1m on the proximal side, fiber stop green 235mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 10m +/-0,05m, sterile EO, disposable, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN210138S0 Catalog Number :

Device Description : Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420 Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, freestanding SMA 905, black protection cap, extension sleeve silver, black PVC protection tube OD 1,5mm over 3m+/-0,1m on the proximal side, fiber stop blue 235mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 10m +/-0,05m, sterile EO, disposable, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN210167S0 Catalog Number :

Device Description : Laser Surgery Fiber, core 600µm, clad 660µm, fiber OD 870µm, blue Tefzel Jacket, Laser Surgery Fiber, core 600µm, clad 660µm, fiber OD 870µm, blue Tefzel Jacket, SMA 905 holmium connector with knurl nut, black protection cap, engraved extension sleeve red, black bend protection, distal flat tip, cleaved, 3mm stripped, NA 0.22, length 3m +/-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 - EOBN220051S0 Catalog Number :

Device Description : Laser Surgery Fiber, core 400µm, clad 420µm, fiber OD 950µm, white Vestodur Jack Laser Surgery Fiber, core 400µm, clad 420µm, fiber OD 950µm, white Vestodur Jacket with length marking, standard SMA 905 connector with knurl nut, PEEK protection cap, engraved extension sleeve red, black bend protection, distal flat tip, cleaved, NA 0.22, length 3m +/-0,2m, sterile EO, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN220126S0 Catalog Number :

Device Description : Laser Surgery Fiber, core 600µm, clad 660µm, fiber OD 870µm, blue Tefzel Jacket, Laser Surgery Fiber, core 600µm, clad 660µm, fiber OD 870µm, blue Tefzel Jacket, SMA 905 holmium connector with knurl nut, PEEK protection cap, engraved extension sleeve red, black bend protection, distal flat tip, cleaved, 3mm stripped, NA 0.22, length 3m +/-0,2m, sterile EO, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN230031S0 Catalog Number :

Device Description : Laser Surgery Fiber, core 320µm, clad 385µm, fiber OD 415µm, polyimide coating, 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,

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN230051N0 Catalog Number :

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN230052N0 Catalog Number :

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN230053S0 Catalog Number :

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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