Orthopaedic Surgical Instruments
FDA UDIEUDAMEDClass I (US FDA UDI)
by Citieffe
Identity
- Trade Name
- SURGICAL INSTRUMENTS (IIA) EUDAMEDOrthopaedic Surgical Instruments FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, rigid FDA UDI
- Device Name
- SURGICAL INSTRUMENTS (IIA) EUDAMED
- Model / Reference
- Reamers EUDAMED5103-150 EUDAMEDReamer head ø15mm, hole ø3.5mm FDA UDI
Identifiers
- Catalog Number
- 5103-150 FDA UDI
- Primary DI / UDI-DI
- 08056711921389 EUDAMEDFDA UDI
- Basic UDI-DI
- 803290962103BL EUDAMED
- Direct Marketing DI
- 08056711921389 EUDAMED
- FDA Product Code
- HTO FDA UDI
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
- GMDN Term
- Medullary canal orthopaedic reamer, rigid FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Medullary canal orthopaedic reamer, rigid
Orthopaedic Surgical Instruments by Citieffe — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Medullary canal orthopaedic reamer, rigid.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Citieffe
Sources (2)
- FDA UDI 6bb116b3-ec79-409b-8931-9978f0e0535f 35 fields · synced Sep 17, 2026
- EUDAMED eac3292c-f7bb-4a15-b212-101415fc9346 61 fields · synced Sep 17, 2026