FDA UDI
In Commercial Distribution
🇺🇸 United States
MyoVision SoloVision Hub
DI: 00864021000339
·
Model: D11
·
PRECISION BIOMETRICS INC
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MyoVision SoloVision Hub
- Primary DI
- 00864021000339
- Version / Model
- D11
- Company Name
- PRECISION BIOMETRICS INC
- Labeler DUNS
- 362997926
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-15
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- e75adcc3-6f92-4dda-995c-6e96d5df7214
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
- 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 |
|---|---|---|---|---|
| KQX | Goniometer, Ac-Powered | Orthopedic | 888.1500 | 1 |
| HCS | Device, Temperature Measurement, Direct Contact, Powered | Neurology | 882.1570 | 2 |
| HCC | Device, Biofeedback | Neurology | 882.5050 | 2 |
| IKN | Electromyograph, Diagnostic | Physical Medicine | 890.1375 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32521 | Multiple physiological signal amplifier | An electronic device that increases current, voltage, or power to adjust the signal level and impedance between two or more medical devices transmitting physiological signals; or the device has the capability of being used for more than a single application, such as electroencephalography (EEG), evoked potential, polysomnography (sleep analysis) and general polygraphy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00864021000339 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123399 | 000 |