Orascoptic - HDL 3.0 Rx

Basic Information

• Brand Name: Orascoptic - HDL 3.0 Rx
• Primary DI: 00615375009857
• Version / Model: HDL 3.0 Rx
• Company Name: METREX RESEARCH, LLC
• Labeler DUNS: 145963778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 1
• Public Version Date: 2022-12-16
• Public Version Status: New
• Public Device Record Key: e608aa51-5e6c-4c3c-aca3-7d320ad45096

Device Description

NA

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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	00615375009857	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm