Wise Iridotomy-Sphincterotomy Laser Lens

Basic Information

• Brand Name: Wise Iridotomy-Sphincterotomy Laser Lens
• Primary DI: 00630238007597
• Version / Model: OWISA
• Company Name: OCULAR INSTRUMENTS, INC.
• Labeler DUNS: 046212387
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-09
• Public Version: 4
• Public Version Date: 2018-09-24
• Public Version Status: Update
• Public Device Record Key: 9129b430-a44f-43c0-b0ac-4bca5d5f3718

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: High-level Disinfectant

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
40238	Laser lens, ophthalmic, surgical	A device designed to modify the convergence of the rays of light of an ophthalmic laser beam used to coagulate or cut tissues of the eye, the orbit, or the surrounding skin.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630238007597	GS1
Direct Marking	00630238020046	GS1

Premarket Submissions

Submission Number	Supplement Number
K861648	000