Identity
- Trade Name
- StimRouter User Kit FDA UDI
- Generic Name
- Analgesic PENS system probe, single-use FDA UDI
- Device Name
- External Pulse Transmitter (EPT) FDA UDI
- Model / Reference
- ST2-5000 FDA UDI
- Description
- External Pulse Transmitter (EPT) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815962020030 FDA UDI
- FDA Product Code
- GZF FDA UDI
- GMDN Term
- Analgesic PENS system probe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Analgesic PENS system probe, single-use
StimRouter User Kit by Bioness Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Analgesic PENS system probe, single-use.
- Biowave Percutaneous Electrodes — BioWave Corporation · Class II
- Biowave Percutaneous Electrodes — BioWave Corporation · Class II
- StimRouter Clinician's Kit — BIONESS INC. · Class II
- StimRouter Implantable Kit — BIONESS INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bioness Inc.
Sources (1)
- FDA UDI ba2d7f00-9a90-4a0d-8959-4230fb82f98a 34 fields · synced May 30, 2026