Identity
- Trade Name
- ROMEO® 2 FDA UDI
- Generic Name
- Orthopaedic cement injection cannula FDA UDI
- Device Name
- CEMENT FILLER PP FDA UDI
- Model / Reference
- ELL-IN 00 42-S FDA UDI
- Description
- CEMENT FILLER PP FDA UDI
Identifiers
- Catalog Number
- ELL-IN 00 42-S FDA UDI
- Primary DI / UDI-DI
- 07640151088323 FDA UDI
- FDA Product Code
- PML FDA UDINKB FDA UDIKWP FDA UDI
- GMDN Term
- Orthopaedic cement injection cannula FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 FDA UDI888.3070 FDA UDI888.3050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic cement injection cannula
Romeo® 2 by Spineart — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Spineart
Sources (1)
- FDA UDI 59aade53-32c9-40dd-9947-3392a3128330 34 fields · synced May 30, 2026