Ocutech

Primary DI
00850008829772
Brand
Ocutech
Company
Ocutech, Inc.
Model
SideSight
Catalog number
A8000
Device description
Battery-operated ultrasonic sensor attached to eyeglasses that warns the wearer of an obstacle they may collide with in the non-seeing visual field.
Published
2024-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
HPGAid, Vision, Electronic, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPGAid, Vision, Electronic, Battery-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008829772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008829772008500088297728500088297720850008829772

GMDN Terms#

Term, Definition table
TermDefinition
Assistive echolocation deviceAn electrically-powered, body-worn device intended to be used as a mobility aid for a patient with a visual impairment by providing feedback on their local environment using ultrasound-based echolocation. It includes an ultrasound transceiver designed to detect nearby obstacles by echolocation and which communicates this information to the wearer using vibration patterns. It is available as a wearable device (e.g., wristband, spectacle frame attachment) which might additionally include an internal compass and might be designed to interface with the navigation features on a smartphone.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
145767323
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850008829758Ocutech VES Falc 5.5xA90052020-04-01
00850008829765Ocutech Sightscope NearviewA7017.NV2020-04-01