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IM reamer shaft dove tail 470 mm, Stryker/Zimmer-Hall coup.
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- IM reamer shaft dove tail 470 mm, Stryker/Zimmer-Hall coup. FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, flexible FDA UDI
- Device Name
- Intramedullary reamer shaft is used in combination with the Intramedullary reamer head to ream the medullary cavity of long bones in traumatologic or limb lengthening surgery of the femur, tibia and humerus bones where medullary cavities need to be prepared prior to placing a nail. The intramedullary reamers are intended for use with a guide wire to permit to secure the assembly and a surgical drilling machine. The device is reusable. FDA UDI
- Model / Reference
- T18820 FDA UDI
- Description
- Intramedullary reamer shaft is used in combination with the Intramedullary reamer head to ream the medullary cavity of long bones in traumatologic or limb lengthening surgery of the femur, tibia and humerus bones where medullary cavities need to be prepared prior to placing a nail. The intramedullary reamers are intended for use with a guide wire to permit to secure the assembly and a surgical drilling machine. The device is reusable. FDA UDI
Identifiers
- Catalog Number
- T18820 FDA UDI
- Primary DI / UDI-DI
- 07640187918144 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, Stryker/Zimmer-Hall 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.
- MODULAR FLEXIBLE REAMER HEAD, Ø10.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- Patella Inlay Reamer Size 5 — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
- ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc. · Class II
- ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc. · Class II
- 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 4c91582d-f449-4fc3-921c-f9866d28cfc9 35 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 1, 2026