Identity
- Trade Name
- Luxe™ 2.5 Semi-custom loupe FDA UDI
- Generic Name
- Surgical binoculars, reusable FDA UDI
- Device Name
- Luxe™ 2.5 Semi-custom loupe demo bag with 9 demo loupes: Model No. DI Number Device Description 922537-1 00850036373377 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic amethyst frame, near PD, short WD, demo only 922537-2 00850036373384 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic amethyst frame, near PD, regular WD, demo only 922537-3 00850036373391 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic amethyst frame, near PD, long WD, demo only 922538-1 00850036373407 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic slate frame, regular PD, short WD, demo only 922538-2 00850036373414 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic slate frame, regular PD, regular WD, demo only 922538-3 00850036373421 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic slate frame, regular PD, long WD, demo only 922539-1 00850036373438 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, sport black frame, wide PD, short WD, demo only 922539-2 00850036373445 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, sport black frame, wide PD, regular WD, demo only 922539-3 00850036373452 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, sport black frame, wide PD, long WD, demo only FDA UDI
- Model / Reference
- 922464-2 FDA UDI
- Description
- Luxe™ 2.5 Semi-custom loupe demo bag with 9 demo loupes: Model No. DI Number Device Description 922537-1 00850036373377 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic amethyst frame, near PD, short WD, demo only 922537-2 00850036373384 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic amethyst frame, near PD, regular WD, demo only 922537-3 00850036373391 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic amethyst frame, near PD, long WD, demo only 922538-1 00850036373407 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic slate frame, regular PD, short WD, demo only 922538-2 00850036373414 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic slate frame, regular PD, regular WD, demo only 922538-3 00850036373421 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic slate frame, regular PD, long WD, demo only 922539-1 00850036373438 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, sport black frame, wide PD, short WD, demo only 922539-2 00850036373445 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, sport black frame, wide PD, regular WD, demo only 922539-3 00850036373452 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, sport black frame, wide PD, long WD, demo only FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850036373469 FDA UDI
- FDA Product Code
- FSP FDA UDI
- GMDN Term
- Surgical binoculars, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical binoculars, reusable
Luxe™ 2.5 Semi-custom loupe by Metrex Research — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical binoculars, reusable.
- Brilliance — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class I
- Enova Illumination — ENOVA ILLUMINATION, INC · Class I
- SurgiTel — Surgitel · Class I
- Surgical Telescope — Xenosys Co., Ltd. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- SuperVu XL Advantage 3.5x, at 34cm working distanc — Rudolf Riester GmbH & Co. KG · Class I
- Surgical Telescope — Xenosys Co., Ltd. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Metrex Research
Sources (1)
- FDA UDI 66f0c619-3aa5-4460-a1fd-04126831dffb 34 fields · synced May 30, 2026