OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER
OBERON GMBH FIBER TECHNOLOGIES
OBERON GMBH FIBER TECHNOLOGIES
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011310540 | 3011310540 | OBERON GMBH FIBER TECHNOLOGIES | 1 | N | 2026-01-01 | Ludwig-Witthoeft-Strasse 14 Wildau Brandenburg DE 15745 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 176174 | 1071756034 | K140470 | OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER | GEX | 2014-10-15 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GEX | 1 | 2014-10-15 |
PMN#
GUDID#
NA - Laser Surgery Fiber, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon, standard SMA 905 connector with knurl nut, black protection cap, RFID extension sleeve red with HID Glass Tag HF VIGO, black bend protection, distal flat tip, cleaved, NA 0.22, length 2m +/-0,2m, sterile EO, disposable, double packed,
2026-07-22
NA - Laser Surgery Fiber, core 600µm, clad 660µm, fiber OD 890µm, blue Tefzel Jacket, freestanding 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, reusable, double packed
2024-07-24
NA - Laser Surgery Fiber, core 365µm, clad 400µm, fiber OD 580µm, blue Tefzel Jacket, standard SMA 905 connector with knurl nut, black protection cap, extension sleeve red engraved, black bend protection, LUER adapter, distal ball tip, NA 0.22, length 3m +/-0,2m, sterile EO, disposable, double packed
2024-07-17
NA - Laser Surgery Fiber, core 365µm, clad 400µm, fiber OD 580µm, blue Tefzel Jacket, standard SMA 905 connector with knurl nut, black protection cap, extension sleeve red engraved, black bend protection, LUER adapter, distal ball tip, NA 0.22, length 3m +/-0,2m, sterile EO, disposable, double packed
2024-07-17
NA - Radial Emission Fiber, core 400µm, clad 420µm, fiber OD 950µm, 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 1000µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed
2024-06-11
NA - 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
2024-06-11
NA - Radial Emission Fiber, core 550µm, clad 578µm, fiber OD 1300µm, white Tefzel Jacket, 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
2024-06-11
NA - Proctology - Hemorrhoid Fiber Probe, core 550µm, clad 578µm, fiber OD 1300µm, white Tefzel Jacket, standard SMA 905 connector with knurl nut, black protection cap, extension sleeve red, black bend protection, LUER adapter, distal flat tip with silica conical capillary dome, capillary OD 1800µm, NA 0.22, length 3m +/-0,2m, sterile EO, disposable, double packed
2024-06-11
NA - Laser Surgery Fiber, core 600µm, clad 660µm, fiber OD 890µm, blue Tefzel Jacket, freestanding SMA 905 connector with knurl nut, PEEK protection cap, 7cm black bend protection (heat shrink tube), distal flat tip, cleaved, NA 0.22, length 3m +/-0,1m, sterile EO, double packed
2024-01-24
NA - 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
2022-03-17
NA - 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
2022-03-17
NA - 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
2022-03-17
NA - 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
2022-03-17
NA - 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
2021-12-23
NA - 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
2021-12-23
NA - 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
2021-08-16
NA - 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
2021-08-16
NA - 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
2017-06-09
NA - 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
2019-01-15
NA - 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
2019-01-15
NA - 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
2019-01-15
NA - 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
2019-01-15
NA - 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
2019-01-15
NA - 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
2019-01-15
NA - 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
2019-01-15
NA - 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
2019-01-15
NA - 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
2017-02-18
NA - 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,
2017-02-18
NA - Laser Surgery Fiber - Dental Bare Fiber 200µm
2019-01-24
NA - Laser Surgery Fiber - Dental Bare Fiber 320µm
2019-01-24
NA - Laser Surgery Fiber - Chirurgie Bare Fiber 320µm
2019-01-24
NA - 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
2017-02-18
NA - 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
2017-02-18
NA - 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
2017-02-18
NA - 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
2019-01-15
NA - 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
2019-01-15
NA - 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
2019-01-15
NA - 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
2019-01-15