Volk Infusion Handle

Basic Information

• Brand Name: Volk Infusion Handle
• Primary DI: 00811608016412
• Version / Model: VINFHAN
• Company Name: VOLK OPTICAL INC.
• Labeler DUNS: 071125835
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-06
• Public Version: 1
• Public Version Date: 2023-01-16
• Public Version Status: New
• Public Device Record Key: f57cf925-885c-4320-866a-db14e39fca7f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Manufacturing Date: Yes
• 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
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	886.4360	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63231	Ophthalmic surgical irrigation/infusion/aspiration handle, reusable	A hand-held, manual tubular device designed as an interface between an ophthalmic cannula intended for infusion, irrigation and/or aspiration (e.g., a capsular polishing or a cystotome cannula) and associated tubing, to facilitate manipulation of the cannula. It is typically made of metal or a durable polymer and is in the form a cylinder, that has a Luer fitting at the distal end, for connection to the cannula. It is typically used in cataract surgery. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811608016412	GS1

Customer Contacts

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