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
10871321002526LabVit KitLVK1000, LVK1100N/A2018-02-26
00871321000297Labtician Lid Load Adhesive StripsNST 400NST 4002018-08-07
10871321001369Grooved SpongeS 1983-3.22015-10-05
10871321001628Silicone Tire 10mmS 29772015-10-09
10871321001635Meridional Implant - FlatS 29782015-10-09
10871321001642Silicone Tire 7mmS 29862015-10-09
10871321001659Circling BandS 29872015-10-09
108713210016662.5mm Circling BandS 2987-M2018-02-22
10871321001673Meridional ImplantS 29882015-10-09
10871321001680BoatS 29892015-10-09
10871321001697Silicone Tire 9mmS 29912015-10-09
10871321001703Silicone StripS 29922015-10-09
108713210017102.5mm Grooved StripS 2992-M2018-02-22
10871321001727PadS 29932015-10-09
10871321001734Silicone Tire 6.0mmS 29942015-10-09
10871321001741Silicone Tire 8.5mmS 29952015-10-09
10871321001758Silicone Tire 10mmS 29962015-10-09
10871321001765Silicone Tire 10mm LGS 2996 L2015-10-09
10871321001772Silicone Tire 12.5mmS 29972015-10-09
10871321001789Silicone StripS 29982015-10-09