Single Use 3-Mirror Gonio

Basic Information

• Brand Name: Single Use 3-Mirror Gonio
• Primary DI: 00811608019123
• Version / Model: V3MIRD
• Company Name: VOLK OPTICAL INC.
• Labeler DUNS: 071125835
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-25
• Public Version: 1
• Public Version Date: 2020-10-05
• Public Version Status: New
• Public Device Record Key: 28f88425-b2b9-4bfc-8699-038caba3d7c4

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKS	Prism, Gonioscopic	Ophthalmic	886.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11894	Gonioscope	A device intended to be used to examine the angle of the anterior chamber of the eye and for demonstrating ocular motility and rotation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10811608019120	GS1	BOX	10	In Commercial Distribution
Primary	00811608019123	GS1
Package	20811608019127	GS1	CARTON	100	In Commercial Distribution
Package	30811608019124	GS1	CASE	400	In Commercial Distribution

Customer Contacts

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