Identity
- Trade Name
- EBA2 FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, rigid FDA UDI
- Model / Reference
- Trochanteric drill FDA UDI
Identifiers
- Catalog Number
- EBA-5015 FDA UDI
- Primary DI / UDI-DI
- 08032909627721 FDA UDI
- 510(k) Number
- K131005 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Medullary canal orthopaedic reamer, rigid FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 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
No
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: Medullary canal orthopaedic reamer, rigid
Eba2 by Citieffe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Medullary canal orthopaedic reamer, rigid.
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- Legion — Smith & Nephew, Inc. · Class II
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
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 |
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Manufacturer
- Manufacturer
- Citieffe
Sources (1)
- FDA UDI b3c7f342-0a80-4db0-afe5-fd5da8b91c52 36 fields · synced May 31, 2026