FDA UDI
In Commercial Distribution
🇺🇸 United States
Ocutech
DI: 00850008829772
·
Model: SideSight
·
Ocutech, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ocutech
- Primary DI
- 00850008829772
- Version / Model
- SideSight
- Catalog Number
- A8000
- Company Name
- Ocutech, Inc.
- Labeler DUNS
- 145767323
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-12
- Public Version
- 1
- Public Version Date
- 2024-02-20
- Public Version Status
- New
- Public Device Record Key
- d79196e9-bfa7-4ed4-b9fb-504b963d6fe7
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HPG | Aid, Vision, Electronic, Battery-Powered | Ophthalmic | 886.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65083 | Assistive echolocation device | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850008829772 | GS1 |