Oph.Scissors

Basic Information

• Brand Name: Oph.Scissors
• Primary DI: 00857365004552
• Version / Model: 08-14522
• Catalog Number: 08-14522
• Company Name: KATENA PRODUCTS, INC.
• Labeler DUNS: 085668598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-22
• Public Version: 3
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: ef46993e-8070-402c-8f78-9c880039354e

Device Description

Chu Foldable Lens Cutter, Angled

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: 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
HNF	SCISSORS, OPHTHALMIC	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63481	Intraocular lens removal scissors, conventional-hinge, reusable	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut an intraocular lens (IOL) during IOL removal. It comprises two pivoted blades which cut with a shearing action directly adjacent to the handles (i.e., not a probe-like device). It is typically metallic with tweezers-like handles, and is available with various blade designs and sizes; some designs may additionally be used for cutting sutures and drapes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857365004552	GS1

Customer Contacts

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