Boucher DeGroot Head Positioning Glasses

Basic Information

• Brand Name: Boucher DeGroot Head Positioning Glasses
• Primary DI: 00871321002949
• Version / Model: 8080
• Company Name: Labtician Ophthalmics, Inc
• Labeler DUNS: 248911026
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-26
• Public Version: 4
• Public Version Date: 2021-01-27
• Public Version Status: Update
• Public Device Record Key: cf4939be-b1e8-4cd4-837b-d46c46210b80

Device Description

Reader, prism, ophthalmic (glasses)

Device Characteristics

• Single Use: Yes
• 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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HJX	Reader, Prism, Ophthalmic	Ophthalmic	886.5810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32701	Magnifying prism reader	An ophthalmic device (a prism reader) consisting of a magnifying lens intended to magnify the print of reading material and to be used by a patient/person with impaired vision lying in a supine position. The device is placed over the reading material and it changes the angle of the magnified text. It can be made of solid glass or plastic material.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00871321002949	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K000544	000