FDA UDI
In Commercial Distribution
🇺🇸 United States
SonicEye® Dual-Array Ultrasound System
DI: 00850012978008
·
Model: SDA-001
·
SONIVATE MEDICAL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SonicEye® Dual-Array Ultrasound System
- Primary DI
- 00850012978008
- Version / Model
- SDA-001
- Company Name
- SONIVATE MEDICAL, INC.
- Labeler DUNS
- 135945496
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-18
- Public Version
- 2
- Public Version Date
- 2020-06-11
- Public Version Status
- Update
- Public Device Record Key
- 2d2c9c19-d25c-4ea3-9cc3-235dec614b8f
Device Description
Lightweight, battery-powered ultrasound system with dual-array fingertip transducer. Transducer incorporated a high-frequency liner array and a low-frequency phased array.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60924 | Hand-held ultrasound imaging system, body-surface | A battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed. It is not designed to be inserted into the vagina or rectum. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850012978008 | GS1 |
Customer Contacts
- Phone
- 971-220-7871
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192253 | 000 |