SportMeds Instruments
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Cortical Reamer Pin EUDAMEDSportMeds Instruments FDA UDI
- Generic Name
- Arthroscopic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- 4.5mm Cortical Reamer Pin FDA UDI
- Model / Reference
- 05.05.10.0135 EUDAMEDFDA UDISportsmed K-wire / Wire / Pin / Peg / Plug / Screw EUDAMED
- Description
- 4.5mm Cortical Reamer Pin FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630345701572 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014274LSD0182R005L EUDAMED
- FDA Product Code
- NBH FDA UDI
- EMDN Code
- K030299 ARTHROSCOPY SURGICAL INSTRUMENTS, SINGLE USE - OTHER EUDAMED
- GMDN Term
- Arthroscopic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
No
Implantable
No
Reusable
No
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
No
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: Arthroscopic surgical procedure kit, non-medicated, reusable
SportMeds Instruments by Medacta International — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Arthroscopic surgical procedure kit, non-medicated, reusable.
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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
- Medacta International
Sources (2)
- FDA UDI e14ac486-17d1-4c3e-98d0-64bca928d332 33 fields · synced Oct 8, 2026
- EUDAMED f4ab737a-b38b-4f8e-a957-4006e61e8131 61 fields · synced Oct 8, 2026