Luxe™ 2.5 Semi-custom loupe

Basic Information

• Brand Name: Luxe™ 2.5 Semi-custom loupe
• Primary DI: 00850036373469
• Version / Model: 922464-2
• Company Name: METREX RESEARCH, LLC
• Labeler DUNS: 145963778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-12
• Public Version: 1
• Public Version Date: 2024-09-20
• Public Version Status: New
• Public Device Record Key: 66f0c619-3aa5-4460-a1fd-04126831dffb

Device 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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32692	Surgical binoculars, reusable	A pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention. Also known as a surgical loupe, it may be mounted onto the spectacle frames and positioned in front of the spectacle lenses or attached directly onto each of the spectacle lenses. It may also be connected to an external light source or a head-worn light for visual field illumination. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850036373469	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]