FDA.reportPublic FDA data

Ocutech

Primary DI
00850008829758
Brand
Ocutech
Company
Ocutech, Inc.
Model
VES Falc 5.5x
Catalog number
A9005
Device description
Spectacle-mounted telescope for the visually impaired
Published
2020-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HKKTelescope, Spectacle, Low-Vision

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKKTelescope, Spectacle, Low-VisionOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008829758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008829758008500088297588500088297580850008829758

GMDN Terms#

Term, Definition table
TermDefinition
Spectacle-mounted telescopeA device that consists of an arrangement of ophthalmic lenses or mirrors designed to be attached to a pair of spectacles and intended to enlarge 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
919-967-6460info@ocutech.com

Regulatory Flags#

DUNS number
145767323
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008829772OcutechSideSightA80002024-02-12
00850008829550OcutechVES K 3x TSA20032020-04-01
00850008829567OcutechVES K 4x TSA20042020-04-01
00850008829574OcutechVES Expl 3x TSA25032020-04-01
00850008829581OcutechVES Expl 4x TSA25042020-04-01
00850008829598OcutechVES Mini 3x TS- Mtd-Monoc-BLKA30032020-04-01
00850008829604OcutechIM 0.5x- Handheld w neck strap w caseA40012020-04-01
00850008829611OcutechVES Sp II 4x TSA52042020-04-01
00850008829628OcutechVES Sp II 5x TSA52052020-04-01
00850008829635OcutechVES Sp II 6x TSA52062020-04-01
00850008829642Ocutech1.7x SS Frame Mtd- BinocA70172020-04-01
00850008829673Ocutech2.2x SS Frame Mtd- BinocA70222020-04-01
00850008829703Ocutech2.2x SS Demo Clip-on System- Binoc- w caseInsta FE 0.5x2020-04-01
00850008829710OcutechInsta TS 2.2xA72342020-04-01
00850008829727OcutechVES Falc 4xA90042020-04-01
00850008829741OcutechVES Falc 3xA90032020-04-01
00850008829765Ocutech Sightscope NearviewA7017.NV2020-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850008829550OcutechOcutech, Inc.HKK2020-04-01
00850008829567OcutechOcutech, Inc.HKK2020-04-01
00850008829574OcutechOcutech, Inc.HKK2020-04-01
00850008829581OcutechOcutech, Inc.HKK2020-04-01
00850008829598OcutechOcutech, Inc.HKK2020-04-01
00850008829604OcutechOcutech, Inc.HKK2020-04-01
00850008829611OcutechOcutech, Inc.HKK2020-04-01
00850008829628OcutechOcutech, Inc.HKK2020-04-01
00850008829635OcutechOcutech, Inc.HKK2020-04-01
00850008829642OcutechOcutech, Inc.HKK2020-04-01
00850008829673OcutechOcutech, Inc.HKK2020-04-01
00850008829703OcutechOcutech, Inc.HKK2020-04-01
00850008829710OcutechOcutech, Inc.HKK2020-04-01
00850008829727OcutechOcutech, Inc.HKK2020-04-01
00850008829741OcutechOcutech, Inc.HKK2020-04-01
00850008829765Ocutech Ocutech, Inc.HKK2020-04-01