Identity
- Trade Name
- NeuLight® FDA UDI
- Generic Name
- Urogenital surgical laser system beam guide, reusable FDA UDI
- Model / Reference
- WFR-200-SB FDA UDI
Identifiers
- Catalog Number
- 099071 FDA UDI
- Primary DI / UDI-DI
- 00816901024058 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Urogenital surgical laser system beam guide, reusable
NeuLight® by WEINERT Fiber Optics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urogenital surgical laser system beam guide, reusable.
- Flexguide Ultra Handpiece — OMNIGUIDE, INC. · Class II
- Elevate™ENT Handpiece 22cm 45°/15° -S — OMNIGUIDE, INC. · Class II
- MaxiFlex Holmium Laser Fiber — MAXIFLEX, LLC · Class II
- Elevate™ENT Handpiece 17cm 45°/15° — OMNIGUIDE, INC. · Class II
- MaxiFlex Holmium Laser Fiber — MAXIFLEX, LLC · Class II
- Core GYN Tray — OMNIGUIDE, INC. · Class II
- NEURO Handpiece, 8cm, Straight — OMNIGUIDE, INC. · Class II
- Elevate ENT Handpiece 5cm 0° -S — OMNIGUIDE, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- WEINERT Fiber Optics Inc.
Sources (1)
- FDA UDI ae2ef375-5de6-45f6-9f57-5d4a24bff40d 33 fields · synced Jun 8, 2026