FRESNEL PRISM AND LENS

Basic Information

• Brand Name: FRESNEL PRISM AND LENS
• Primary DI: 00850029104698
• Version / Model: 3020-F
• Catalog Number: 3020-F
• Company Name: Fresnel Prism & Lens Company
• Labeler DUNS: 789337987
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-05
• Public Version: 1
• Public Version Date: 2023-02-13
• Public Version Status: New
• Public Device Record Key: 590eda88-15d6-4574-98bd-0a7e0b8ede24

Device Description

FRESNEL LENS, D-SEGMENT, 2.0 DIOPTER

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKT	Prism, Fresnel, Ophthalmic	Ophthalmic	886.1655	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32693	Fresnel lens	A very thin and flexible ophthalmic lens intended to be applied to the back of spectacle lenses to focus light to a focal point to help manage various vision conditions including aphakia (absence of the lens of the eye), myopia, hyperopia, and presbyopia. It is typically made of glass or plastic and its surface is a concentric series of increasingly refractive zones.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850029104698	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: STORE AT ROOM TEMPERATURE, AVOID EXESSIVE HEAT AND HUMIDITY