FDA.reportPublic FDA data

Boucher DeGroot Head Positioning Glasses

Primary DI
00871321002949
Brand
Boucher DeGroot Head Positioning Glasses
Company
Labtician Ophthalmics, Inc
Model
8080
Device description
Reader, prism, ophthalmic (glasses)
Published
2018-02-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJXReader, Prism, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJXReader, Prism, OphthalmicOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000544000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000544000BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080Labtician Ophthalmics, Inc.2000-03-09HJX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00871321002949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00871321002949008713210029498713210029490871321002949

GMDN Terms#

Term, Definition table
TermDefinition
Magnifying prism readerAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905-829-0055philcuscuna@labtician.com

Regulatory Flags#

DUNS number
248911026
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00871321000013Oval SpongeS 1981-42026-10-01
00871321000020Oval SpongeS 1981-52026-10-01
00871321000044Oval SpongeS 1981-7.52026-10-01
00871321000051Round Sponge 1.5mmS 1982-1.52026-10-01
00871321000068Round Sponge 2mmS 1982-22026-10-01
00871321000075Round Sponge 2.5mmS 1982-2.52026-10-01
00871321000082Round Sponge 3mmS 1982-32026-10-01
008713210000993.0mm Round SpongeS 1982-3-M2026-10-01
00871321000105Round Sponge 4mmS 1982-42026-10-01
00871321000112Round Sponge 5mmS 1982-52026-10-01
008713210001295.0mm Round SpongeS 1982-5-M2026-10-01
00871321000136Round Tunnel Sponge 5mmS 1982-5T2026-10-01
00871321000143Round Sponge 7mmS 1982-72026-10-01
00871321000150Round Sponge 7.5mm x 50mmS 1982-7.52026-10-01
00871321000167Grooved SpongeS 1983-2.32026-10-01
00871321000174Grooved Part Thickness SpongeS 1983-2.52026-10-01
00871321000181Grooved Part Thickness SpongeS 1983-2.82026-10-01
00871321000198Grooved SpongeS 1983-32026-10-01
00871321000204Grooved SpongeS 1983-3.22026-10-01
00871321000211Grooved SpongeS 1983-3.52026-10-01