FDA UDI
In Commercial Distribution
🇺🇸 United States
Pathway Pain & Sensory Evaluation System
DI: 07290103039301
·
Model: Pathway
·
MEDOC LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Pathway Pain & Sensory Evaluation System
- Primary DI
- 07290103039301
- Version / Model
- Pathway
- Catalog Number
- MO 00007-12
- 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
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 388e1e56-7f28-4ec9-8f13-3e4e20295ad2
Device Description
The Pathway Pain & Sensory Evaluation System is a computerized thermal stimulator designed for neurological and pain research. Pathway expands the functions offered by Medoc TSA-II, introducing new hardware and software capabilities to expand the quantitative investigation of human nociceptive pathways. The PATHWAY is a pain management and pain research system intended to be used for the quantitative assessment of small nerve fiber dysfunctions. It measures sensory thresholds such as cold and warm sensation and heat-induced pain. The Device includes: main unit, at least one probe/thermode 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
- MR Conditional
- 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 |
|---|---|---|---|---|
| NTU | Evoked Potential Stimulator, Thermal | Neurology | 882.1870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37350 | Thermotester, diagnostic | A mains electricity (AC-powered) device designed to provide quantitative diagnostic evaluation of a patient's reaction to thermal stimuli, typically on the skin surface, by providing information on threshold to heat or cold perception. The device typically operates by gradually increasing the temperature to 42 - 50? Celsius. It is typically used to diagnose early diabetes mellitus, for phantom pain detection, neurological studies of thin fibre nerve systems, and also for pain threshold investigations. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07290103039806 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 07290103039301 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052357 | 000 |