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 - EOBN200029S0 Catalog Number :

Device Description : Laser Surgery Fiber, core 600µm, fiber OD 950µm, transparent Tefzel Jacket, cust Laser Surgery Fiber, core 600µm, fiber OD 950µm, transparent Tefzel Jacket, customized connector, white bend protection (heat shrink tube), LUER adapter, distal flat tip, cleaved, NA 0.37, 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 - EOBN210110S0 Catalog Number :

Device Description : Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 42 Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, PVC protection cap, extension sleeve silver, fiber stop red 144mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 2m +/-0,02m, sterile EO, disposable, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN210111S0 Catalog Number :

Device Description : Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 42 Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, PVC protection cap, extension sleeve silver, fiber stop yellow 144mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 2m +/-0,02m, sterile EO, disposable, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN210112S0 Catalog Number :

Device Description : Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 42 Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, PVC protection cap, extension sleeve silver, fiber stop green 144mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 2m +/-0,02m, sterile EO, disposable, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN210113S0 Catalog Number :

Device Description : Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 42 Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, PVC protection cap, extension sleeve silver, fiber stop blue 144mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 2m +/-0,02m, sterile EO, disposable, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN210114S0 Catalog Number :

Device Description : Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 42 Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, PVC protection cap, extension sleeve silver, fiber stop red 239mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 2m +/-0,02m, sterile EO, disposable, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN210115S0 Catalog Number :

Device Description : Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 42 Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, PVC protection cap, extension sleeve silver, fiber stop yellow 239mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 2m +/-0,02m, sterile EO, disposable, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN210116S0 Catalog Number :

Device Description : Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 42 Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, PVC protection cap, extension sleeve silver, fiber stop green 239mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 2m +/-0,02m, sterile EO, disposable, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN210117S0 Catalog Number :

Device Description : Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 42 Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, PVC protection cap, extension sleeve silver, fiber stop blue 239mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 2m +/-0,02m, sterile EO, disposable, double packed

Device Class : 2

Duns Number: 312889060

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NA - EOBN210135S0 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 red 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

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