Identity
- Trade Name
- Paradigm Revolution FDA UDI
- Generic Name
- Leg procedure positioner FDA UDI
- Device Name
- Paradigm Revolution Table Attachment, JP FDA UDI
- Model / Reference
- PRTA03 FDA UDI
- Description
- Paradigm Revolution Table Attachment, JP FDA UDI
Identifiers
- Catalog Number
- PRTA03 FDA UDI
- Primary DI / UDI-DI
- 30845854082984 FDA UDI
- FDA Product Code
- HST FDA UDI
- GMDN Term
- Leg procedure positioner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.5850 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Leg procedure positioner
Paradigm Revolution by Conmed Corporation — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (2)
- FDA UDI 4587a87a-fc57-452f-900f-0bb7d6fa089e 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026