FDA UDI
In Commercial Distribution
🇺🇸 United States
VSA-3000 Vibratory Sensory Analazer
DI: 07290103039004
·
Model: VSA-3000
·
MEDOC LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- VSA-3000 Vibratory Sensory Analazer
- Primary DI
- 07290103039004
- Version / Model
- VSA-3000
- Catalog Number
- MO 00003
- Company Name
- MEDOC LTD.
- Labeler DUNS
- 600469191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-06-26
- Public Version Status
- Update
- Public Device Record Key
- c633a197-fd9c-425a-8a98-496f4ed5ed30
Device Description
The Vibratory Sensory Analyzer VSA-3000 is a computerized device for the quantitative assessment of large nerve fiber dysfunctions, designed for both clinical and advanced research applications. It measures the sensory threshold for vibration. The Device includes: main unit, at least one probe and accessories.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| IRO | Vibrator, Therapeutic | Physical Medicine | 890.5975 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37349 | Vibratory biothesiometer | An electronic instrument intended to produce vibrations that are applied to a part of the body (often the great toe) in a range of intensities to noninvasively measure vibratory sensation threshold. Sometimes referred to as a vibrameter, It is typically used for neuropathological diagnoses and evaluation of the neurological health effects of diabetes mellitus, exposure to neurotoxic compounds (e.g., solvents or heavy metals), poor ergonomic working conditions, chemotherapy or trauma. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07290103039509 | GS1 | Carton | 1 | In Commercial Distribution | |
| Primary | 07290103039004 | GS1 |