HR Direct Prism Vit (VHRD20PACS)

Basic Information

• Brand Name: HR Direct Prism Vit (VHRD20PACS)
• Primary DI: 00811608013329
• Version / Model: VHRD20PACS
• Company Name: VOLK OPTICAL INC.
• Labeler DUNS: 071125835
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-29
• Public Version: 4
• Public Version Date: 2020-09-30
• Public Version Status: Update
• Public Device Record Key: abca9fb0-9aa8-4a3e-a35b-8ff6d2b1db44

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: Yes
• PM Exempt: Yes
• 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: No

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
58037	Vitrectomy contact lens, reusable	A non-sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), It is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a reusable device that must be sterilized before application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811608013329	GS1

Customer Contacts

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