Identity
- Trade Name
- Polysmith Version 9.0 FDA UDI
- Generic Name
- Sleep disorder interpretive software, professional-only FDA UDI
- Model / Reference
- 9.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817111020755 FDA UDI
- FDA Product Code
- OLZ FDA UDIOLV FDA UDIDQA FDA UDIMNR FDA UDIGWL FDA UDI
- GMDN Term
- Sleep disorder interpretive software, professional-only FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI870.2700 FDA UDI868.2375 FDA UDI882.1835 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Polysmith Version 9.0 by Neurotronics, LLC — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neurotronics, LLC
Sources (1)
- FDA UDI 27fa68a1-3495-446a-8c1a-ce71c37565e6 33 fields · synced May 30, 2026