OPTIVISOR MAGNIFIER

Basic Information

• Brand Name: OPTIVISOR MAGNIFIER
• Primary DI: 00192896096226
• Version / Model: 1103-402
• Catalog Number: 1103-402
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-08
• Public Version: 3
• Public Version Date: 2019-06-12
• Public Version Status: Update
• Public Device Record Key: 232f83cf-f7fa-4ef3-8ff9-a18cb6a3275b

Device Description

OPTIVISOR MAGNIFIER #DA-3

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: 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
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46550	Spectacle-mounted magnifier	A magnifying ophthalmic lens designed to be attached to a pair of spectacles and intended to enlarge text/images for a visually impaired patient/person. It is also known as a magnifying glass and can be made of solid plastic material or glass within a plastic or metal frame.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896096226	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1.75 Magnification at 14 Inches