Single Use 28D

Basic Information

• Brand Name: Single Use 28D
• Primary DI: 00811608018973
• Version / Model: V28LCD
• Company Name: VOLK OPTICAL INC.
• Labeler DUNS: 071125835
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 2
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: efae0247-b649-43f1-af7c-8c749faebe0f

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
HJL	Lens, Condensing, Diagnostic	Ophthalmic	886.1380	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47946	Ophthalmic diagnostic condensing lens	An ophthalmic lens intended to be used during binocular indirect ophthalmoscopy and/or slit lamp examination to focus reflected light from the fundus of the eye. The lens is available in a variety of sizes and optical powers. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10811608018970	GS1	BOX	10	In Commercial Distribution
Primary	00811608018973	GS1
Package	20811608018977	GS1	CARTON	100	In Commercial Distribution
Package	30811608018974	GS1	CASE	400	In Commercial Distribution

Customer Contacts

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