Lorgnette with striated lenses (Bagolini), Axes 45°/123°

Basic Information

• Brand Name: Lorgnette with striated lenses (Bagolini), Axes 45°/123°
• Primary DI: 04049584005878
• Version / Model: 42770
• Company Name: OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
• Labeler DUNS: 317138956
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-16
• Public Version: 1
• Public Version Date: 2023-06-26
• Public Version Status: New
• Public Device Record Key: 9cc3c393-f704-49de-af69-b09aa14b57f4

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
HPD	Lens, Bagolini	Ophthalmic	886.1375	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47945	Bagolini lens/spectacles/lorgnette	An ophthalmic device in the form of a separate lens, spectacles or lorgnette intended to be used to determine/diagnose ophthalmic conditions (e.g., pseudofovea, abnormal retinal correspondence, suppression and diplopia). The lens has narrow striations running parallel in one meridian and can be used in a trial lens frame, or fixed in a spectacles/lorgnette frame, for binocular testing. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049584005878	GS1