Identity
- Trade Name
- Panther OIS|R&V FDA UDI
- Generic Name
- Radiation therapy treatment record/verify system FDA UDI
- Model / Reference
- v2.31 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859032007095 FDA UDI
- FDA Product Code
- IYE FDA UDIMUJ FDA UDI
- GMDN Term
- Radiation therapy treatment record/verify system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
No
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
Panther OIS|R&V by Prowess, Inc. — 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
- Prowess, Inc.
Sources (1)
- FDA UDI ef701fb4-fe93-4685-a42e-f43792559a15 34 fields · synced Jun 8, 2026