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Straight guide Ø2 x 820 mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref T602Model Straight guide
Identity
- Trade Name
- Straight guide Ø2 x 820 mm EUDAMEDFDA UDI
- Generic Name
- Orthopaedic guidewire, reusable FDA UDI
- Device Name
- The straight guide is used to lead intramedullary reamer in its proper course into the medullary canal. The end piece permits to prevent and retain the intramedullary reamer in case of sliding along the guide. The length varies from 440 to 820 mm and the diameter from 2 to 3 mm. Two kind of head, permitting to maintain the intramedullary reamer, exist. This is a reusable device. FDA UDI
- Model / Reference
- Straight guide EUDAMEDT602 EUDAMEDFDA UDI
- Description
- The straight guide is used to lead intramedullary reamer in its proper course into the medullary canal. The end piece permits to prevent and retain the intramedullary reamer in case of sliding along the guide. The length varies from 440 to 820 mm and the diameter from 2 to 3 mm. Two kind of head, permitting to maintain the intramedullary reamer, exist. This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- T602 FDA UDI
- Primary DI / UDI-DI
- 07640187911343 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018791GUIDEWIRE01DC EUDAMED
- Direct Marketing DI
- 07640187911343 EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic guidewire, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Straight guide Ø2 x 820 mm by MPS Micro Precision Systems AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764018791GUIDEWIRE01DC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MPS Micro Precision Systems AG
- EUDAMED SRN
- CH-MF-000032439
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 08508ecb-e3ba-498c-b6ba-44980fa7f49e 61 fields · synced Jun 19, 2026
- FDA UDI 87bf49be-cbec-4efc-b511-286c63950bb4 35 fields · synced May 29, 2026