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Sign in to claim this brandOMNIGUIDE, INC.
US
Last updated May 31, 2026
What OMNIGUIDE, INC. makes
Omniguide, Inc. makes various medical devices, including urogenital and ophthalmic surgical laser system beam guides, dermatological carbon dioxide laser systems, microbial medical gas filters, and electrosurgical handpieces. Their products also include general and multiple surgical diode/carbon dioxide laser systems. Examples of their devices are the Velocity High Performance Fiber, BeamPath OTO Handpiece Set, and NEURO Handpiece Tray.
The company's portfolio is regulated as Class II devices and is listed in the FDA 510(k) and FDA UDI registries. Omniguide, Inc. is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What type of products does Omniguide, Inc. manufacture?
Omniguide, Inc. makes medical devices such as urogenital and ophthalmic surgical laser system beam guides, dermatological carbon dioxide laser systems, and electrosurgical handpieces, which are examples of their product range.
Where is Omniguide, Inc. based?
Omniguide, Inc. is based in the US, as indicated by its country of origin.
Which registries list Omniguide, Inc.'s devices?
The company's devices are listed in the FDA 510(k) and FDA UDI registries, which track medical devices.
How are Omniguide, Inc.'s devices classified?
Omniguide, Inc.'s devices are regulated as Class II devices, indicating their level of risk and required oversight.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- omni-guide.com
- —
- —
- [email protected]
- Phone
- 888-666-4484
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 030124221
Catalogue (76)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Velocity™ High Performance Fiber | 332005 | FDA UDI | Class II | Active |
| BeamPath OTO Handpiece Set | OTO-HS | FDA UDI | Class II | Active |
| NEURO Handpiece Tray | NEURO-TRAY | FDA UDI | Class II | Active |
| NEURO Handpiece, 8cm, Bent | NEURO-HP-8B | FDA UDI | Class II | Active |
| Elevate™ENT Handpiece 17cm 45°/0° -S | 321005 | FDA UDI | Class II | Active |
| BeamPath OTO Handpiece, 4cm working length | OTO-HP-4 | FDA UDI | Class II | Active |
| Lapflex, Laparoscopic Articulating Handpiece- 33cm | 341001 | FDA UDI | Class II | Active |
| Elevate™ENT Handpiece 5cm 25° -S | 321018 | FDA UDI | Class II | Active |
| Flexguide Ultra Handpiece | FLEXGUIDE-ULTRA | FDA UDI | Class II | Active |
| FLEXGUIDE-ULTRA Handpiece Tray | FLEX-TRAY | FDA UDI | Class II | Active |
| Core GYN Tray | 341005 | FDA UDI | Class II | Active |
| NEURO Handpiece, 8cm, Straight | NEURO-HP-8 | FDA UDI | Class II | Active |
| GYN Handpiece, 3.5 cm, Straight | GYN-HP-3.5 | FDA UDI | Class II | Active |
| Elevate™ENT Handpiece 15cm 25°-S | 321004 | FDA UDI | Class II | Active |
| BeamPath GYN-LGT Handpiece Set | GYN-HS-LGT | FDA UDI | Class II | Active |
| GYN Handpiece Mark III, 13 cm | GYN-HP-13 | FDA UDI | Class II | Active |
| Elevate™ENT Handpiece 17cm 45°/30° | 321006 | FDA UDI | Class II | Active |
| ELEVATE™ ENT Instrumentation Set - 13 | 321015 | FDA UDI | Class II | Active |
| Elevate™ENT Handpiece 22cm 45°/30° -S | 321011 | FDA UDI | Class II | Active |
| BeamPath NEURO-L Fiber | NEURO-L | FDA UDI | Class II | Active |
| Gas Filter Unit | ACC-GFU-100 | FDA UDI | Class II | Active |
| Elevate™ENT Handpiece 22cm 45°/15° | 321010 | FDA UDI | Class II | Active |
| GYN Handpiece Mark III, 13 cm Bent | GYN-HP-13B | FDA UDI | Class II | Active |
| OmniGuide® LapFlex Instrument Set | 341003 | FDA UDI | Class II | Active |
| Elevate™ ENT Instrumentation Tray | 321014 | FDA UDI | Class II | Active |
| Elevate™ENT Handpiece 7cm 0°-S | 321002 | FDA UDI | Class II | Active |
| BeamPath OTO-M fiber | OTO-M | FDA UDI | Class II | Active |
| BeamPath OTO-S fiber | OTO-S | FDA UDI | Class II | Active |
| GYN Handpiece, 46 cm, Straight | GYN-HP-46 | FDA UDI | Class II | Active |
| GYN Robotic Handpiece Tray | GYN-TRAY-MIS | FDA UDI | Class II | Active |
| NEURO Handpiece, 3.5cm, Straight | NEURO-HP-3.5 | FDA UDI | Class II | Active |
| GYN-LGT Handpiece Tray | GYN-TRAY-LGT | FDA UDI | Class II | Active |
| Elevate™ENT Handpiece 14cm 21° -S | 321019 | FDA UDI | Class II | Active |
| GYN-LAP Handpiece Tray | GYN-TRAY-LAP-1 | FDA UDI | Class II | Active |
| NEURO Handpiece, 5cm, Straight | NEURO-HP-5 | FDA UDI | Class II | Active |
| NEURO Handpiece, 6cm, Bent | NEURO-HP-6B | FDA UDI | Class II | Active |
| Beacon Advanced Energy CO2 Laser System | 60 Watt | FDA UDI | Class II | Active |
| BeamPath NEURO Handpiece Set | NEURO-HS | FDA UDI | Class II | Active |
| Elevate™ENT Handpiece 17cm 45°/15° | 321007 | FDA UDI | Class II | Active |
| TRIO Handpiece | 1 | FDA UDI | Class II | Active |
| GYN MIS Robotic & Laparoscopic Instrumentation Set | GYN-HS-MIS | FDA UDI | Class II | Active |
| NEURO Handpiece, 10cm, Bent | NEURO-HP-10B | FDA UDI | Class II | Active |
| BeamPath ROBOTIC fiber | ROBOTIC | FDA UDI | Class II | Active |
| Elevate™ ENT Elite Fiber | 322001 | FDA UDI | Class II | Active |
| Elevate ENT Handpiece 5cm 0° -S | 321017 | FDA UDI | Class II | Active |
| ELEVATE™ ENT Instrumentation Set - 11 | 321016 | FDA UDI | Class II | Active |
| FlexGuide ULTRA with Tray | FLEX-ULTRA SET | FDA UDI | Class II | Active |
| Omniguide Select Fiber | 322003 | FDA UDI | Class II | Active |
| FELS Laser System | FELS-25A | FDA UDI | Class II | Active |
| GYN Handpiece Mark III, 6 cm | GYN-HP-6 | FDA UDI | Class II | Active |
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