Boucher DeGroot Head Positioning Glasses

GUDID 00871321002949

Reader, prism, ophthalmic (glasses)

Labtician Ophthalmics, Inc

Magnifying prism reader Magnifying prism reader Magnifying prism reader Magnifying prism reader Magnifying prism reader Magnifying prism reader Magnifying prism reader Magnifying prism reader Magnifying prism reader Magnifying prism reader Magnifying prism reader Magnifying prism reader Magnifying prism reader Magnifying prism reader Magnifying prism reader Magnifying prism reader

• Primary Device ID: 00871321002949
• NIH Device Record Key: cf4939be-b1e8-4cd4-837b-d46c46210b80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Boucher DeGroot Head Positioning Glasses
• Version Model Number: 8080
• Company DUNS: 248911026
• Company Name: Labtician Ophthalmics, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 905-829-0055
• Email: philcuscuna@labtician.com
• Phone: 905-829-0055
• Email: philcuscuna@labtician.com
• Phone: 905-829-0055
• Email: philcuscuna@labtician.com
• Phone: 905-829-0055
• Email: philcuscuna@labtician.com
• Phone: 905-829-0055
• Email: philcuscuna@labtician.com
• Phone: 905-829-0055
• Email: philcuscuna@labtician.com
• Phone: 905-829-0055
• Email: philcuscuna@labtician.com
• Phone: 905-829-0055
• Email: philcuscuna@labtician.com
• Phone: 905-829-0055
• Email: philcuscuna@labtician.com
• Phone: 905-829-0055
• Email: philcuscuna@labtician.com
• Phone: 905-829-0055
• Email: philcuscuna@labtician.com
• Phone: 905-829-0055
• Email: philcuscuna@labtician.com
• Phone: 905-829-0055
• Email: philcuscuna@labtician.com
• Phone: 905-829-0055
• Email: philcuscuna@labtician.com
• Phone: 905-829-0055
• Email: philcuscuna@labtician.com
• Phone: 905-829-0055
• Email: philcuscuna@labtician.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00871321002949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000544

FDA Product Code

• HJX: Reader, Prism, Ophthalmic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-01-27
• Device Publish Date: 2018-02-26

Devices Manufactured by Labtician Ophthalmics, Inc

• 00871321000297 - Labtician Lid Load Adhesive Strips: 2021-08-11 Adhesive Strips used to adhere weight to the outer skin of the upper eyelid.
• 00871321002956 - LLL Proportional 2.0 grams: 2021-04-30
• 10871321001369 - Grooved Sponge: 2021-01-28
• 10871321001628 - Silicone Tire 10mm: 2021-01-28
• 10871321001635 - Meridional Implant - Flat: 2021-01-28
• 10871321001642 - Silicone Tire 7mm: 2021-01-28
• 10871321001659 - Circling Band: 2021-01-28
• 10871321001666 - 2.5mm Circling Band: 2021-01-28 2.5mm Circling Band