Identity
- Trade Name
- Paradigm FDA UDI
- Generic Name
- Optical surgical navigation device tracking system FDA UDI
- Device Name
- Paradigm System Cart FDA UDI
- Model / Reference
- 1100001 FDA UDI
- Description
- Paradigm System Cart FDA UDI
Identifiers
- Catalog Number
- 1100003 FDA UDI
- Primary DI / UDI-DI
- 00850042604007 FDA UDI
- 510(k) Number
- K222291 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Optical surgical navigation device tracking system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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
Paradigm by Proprio — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Proprio
Sources (1)
- FDA UDI 1449665a-0426-4760-9708-92e0ae9904fd 37 fields · synced Jun 8, 2026