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IM reamer shaft dove tail 470 mm, Hudson coup.
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- IM reamer shaft dove tail 470 mm, Hudson coup. FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, flexible FDA UDI
- Model / Reference
- T18819 FDA UDI
Identifiers
- Catalog Number
- T18819 FDA UDI
- Primary DI / UDI-DI
- 07640187918137 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Medullary canal orthopaedic reamer, flexible 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Medullary canal orthopaedic reamer, flexible
IM reamer shaft dove tail 470 mm, Hudson coup. by MPS Micro Precision Systems AG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Medullary canal orthopaedic reamer, flexible.
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- Arthrex® — Arthrex, Inc. · Class I
- NITINOL MODULAR REAMER HUDSON — Biomet Orthopedics, Inc. · Class I
- Dyna Locking IM Nail — CG MedTech Co., Ltd. · Class I
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- MPS Micro Precision Systems AG
Sources (2)
- FDA UDI 187cd9e2-0d19-4021-ac94-a719615a4b94 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026