Identity
- Trade Name
- Dynatron iBOX2 FDA UDI
- Generic Name
- Drug-delivery iontophoresis system generator FDA UDI
- Model / Reference
- DIBOX2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10660584000314 FDA UDI
- FDA Product Code
- EGJ FDA UDI
- GMDN Term
- Drug-delivery iontophoresis system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5525 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 0.225 Pound FDA UDIHeight — 1.3 Inch FDA UDIWidth — 2.66 Inch FDA UDILength — 4.5 Inch FDA UDI
Dynatron iBOX2 by Dynatronics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Dynatronics Corp.
Sources (1)
- FDA UDI 82df4cc2-124c-4129-ab3d-3e827ba9e9bf 36 fields · synced May 31, 2026