SUPER VIEW® Disposable Wide Field Lens Set for RESIGHT®

Basic Information

• Brand Name: SUPER VIEW® Disposable Wide Field Lens Set for RESIGHT®
• Primary DI: 00856222004827
• Version / Model: 40414
• Catalog Number: 40414
• Company Name: INSIGHT INSTRUMENTS, INC.
• Labeler DUNS: 828348391
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: 82246cf0-a972-4b5c-882f-26f17f9385b7

Device Description

1 Each Sterile Disposable RESIGHT® Wide Field Lens

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HJL	Lens, Condensing, Diagnostic	Ophthalmic	886.1380	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47946	Ophthalmic diagnostic condensing lens	An ophthalmic lens intended to be used during binocular indirect ophthalmoscopy and/or slit lamp examination to focus reflected light from the fundus of the eye. The lens is available in a variety of sizes and optical powers. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856222004827	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	18	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 50 Degrees Celsius