Oph.Scissors

Basic Information

• Brand Name: Oph.Scissors
• Primary DI: 00852979003359
• Version / Model: 08-14513
• Catalog Number: 08-14513
• 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: 1
• Public Version Date: 2022-11-30
• Public Version Status: New
• Public Device Record Key: 01f39b64-c985-48cb-addf-2fcc954878a6

Device Description

Utrata Foldable Lens Cutter

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
63486	Intraocular scissors, probe-like, reusable	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut intraocular tissue (e.g., during anterior chamber surgery, vitrectomy). As a complete instrument it comprises two shearing blades at the end of a probe-/cannula-like shaft with a proximal slimline handle, typically operated by squeezing. It is available with various blade designs and sizes. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852979003359	GS1

Customer Contacts

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