SUPER VIEW® Disposable Lens Set for RESIGHT®

Basic Information

• Brand Name: SUPER VIEW® Disposable Lens Set for RESIGHT®
• Primary DI: 00856222004049
• Version / Model: 40219
• Catalog Number: 40219
• 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: 4
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: 23811077-7247-44c5-b347-3e31ea684f56

Device Description

1 Each RESIGHT® Wide Field Lens and 1 Each Hassan-Tornambe Contact 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: No
• 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
HJK	Lens, Contact, Polymethylmethacrylate, Diagnostic	Ophthalmic	886.1385	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58070	Vitrectomy contact lens, single-use	A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.	No	Active
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
Package	10856222004046	GS1	Case	20	In Commercial Distribution
Primary	00856222004049	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K051630	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	13	Millimeter
Outer Diameter	18	Millimeter

Storage Conditions

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