Identity
- Trade Name
- EBA ONE FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, rigid FDA UDI
- Model / Reference
- Cannulated reamer ø16mm FDA UDI
Identifiers
- Catalog Number
- EBA-5275 FDA UDI
- Primary DI / UDI-DI
- 08052990979639 FDA UDI
- 510(k) Number
- K183666 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
Eba One by Citieffe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medullary canal orthopaedic reamer, rigid.
- POLARSTEM — Smith & Nephew, Inc. · Class II
- Intramedullary Reamer, Revision — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
- Comprehensive® Shoulder Instruments — Biomet Orthopedics, Inc. · Class II
- MP Reconstruction System - Instruments — WALDEMAR LINK GmbH & Co. KG · Class I
- Panta® 2 — Ascension Orthopedics, Inc. · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Citieffe
Sources (1)
- FDA UDI d93ef0e8-bac5-4cf0-9e1d-cbadb5ca9000 36 fields · synced May 30, 2026