Identity
- Trade Name
- ROMEO 2 INSTRUMENTATION FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- DRILL Ø3.2 FDA UDI
- Model / Reference
- ELL-IN 00 47-N FDA UDI
- Description
- DRILL Ø3.2 FDA UDI
Identifiers
- Catalog Number
- ELL-IN 00 47-N FDA UDI
- Primary DI / UDI-DI
- 07640178981850 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Fluted surgical drill bit, reusable
Romeo 2 Instrumentation by Spineart — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Spineart
Sources (1)
- FDA UDI 1e970ccf-1fb9-439c-a572-24758d6855f4 34 fields · synced May 31, 2026