Ophthalmic Forceps

Basic Information

• Brand Name: Ophthalmic Forceps
• Primary DI: 00841668107690
• Version / Model: K5-8228
• Catalog Number: K5-8228
• Company Name: KATENA PRODUCTS, INC.
• Labeler DUNS: 085668598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-14
• Public Version: 2
• Public Version Date: 2022-12-15
• Public Version Status: Update
• Public Device Record Key: 760fa5f1-c783-4a5b-a554-ef9694b8d180

Device Description

ERNEST-MCDONALD IOL INSERTER

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
HNR	Forceps, ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63413	Ophthalmic implant handling forceps, reusable	A hand-held manual ophthalmic surgical instrument with small blades designed to grasp and manipulate ophthalmic implants (excluding sutures) during implantation/explantation; it is not intended for use on tissues. Its design may be tweezers-like, or it may be probe-like with a proximal handle, a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. 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	00841668107690	GS1

Customer Contacts

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