Identity
- Trade Name
- Elevate™ENT Handpiece 17cm 45°/0° -S FDA UDI
- Generic Name
- Urogenital surgical laser system beam guide, reusable FDA UDI
- Device Name
- Elevate™ENT Handpiece FDA UDI
- Model / Reference
- 321005 FDA UDI
- Description
- Elevate™ENT Handpiece FDA UDI
Identifiers
- Catalog Number
- 321005 FDA UDI
- Primary DI / UDI-DI
- 00894338002771 FDA UDI
- 510(k) Number
- K081939 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Urogenital surgical laser system beam guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Urogenital surgical laser system beam guide, reusable
Elevate™ENT Handpiece 17cm 45°/0° -S by Omniguide, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K081939 also covers:
- BeamPath GYN-LAP Handpiece Set — OMNIGUIDE, INC.
- BeamPath GYN-LGT Handpiece Set — OMNIGUIDE, INC.
- BeamPath NEURO Handpiece Set — OMNIGUIDE, INC.
- BeamPath OTO Handpiece Set — OMNIGUIDE, INC.
- BeamPath OTO Handpiece, 4cm working length — OMNIGUIDE, INC.
- Core GYN Tray — OMNIGUIDE, INC.
- ELEVATE™ ENT Instrumentation Set - 11 — OMNIGUIDE, INC.
- ELEVATE™ ENT Instrumentation Set - 13 — OMNIGUIDE, INC.
- Elevate ENT Handpiece 5cm 0° -S — OMNIGUIDE, INC.
- Elevate™ ENT Instrumentation Tray — OMNIGUIDE, INC.
- Elevate™ENT Handpiece 14cm 21° -S — OMNIGUIDE, INC.
- Elevate™ENT Handpiece 15cm 25°-S — OMNIGUIDE, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Omniguide, Inc.
Sources (1)
- FDA UDI 1e1c757b-4b09-47ef-89fb-a87f3414575d 35 fields · synced Jun 1, 2026