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multiSTATION® monoDOC™ RAIL CLAMP
EUDAMEDFDA UDIClass I (EU MDR)
Ref 081022Model 080900
Identity
- Trade Name
- multiSTATION® monoDOC™ RAIL CLAMP EUDAMEDminiARM® multiSTATION™ System FDA UDI
- Generic Name
- Surgical instrument assist arm system, manually-adjusted FDA UDI
- Device Name
- multiSTATION® SubX™ STERNAL ASCENDER™ SYSTEM EUDAMEDminiARM® monoDOC™ Rail Clamp FDA UDI
- Model / Reference
- 080900 EUDAMED081022 EUDAMEDFDA UDI
- Description
- miniARM® monoDOC™ Rail Clamp FDA UDI
Identifiers
- Catalog Number
- 081022 FDA UDI
- Primary DI / UDI-DI
- 00850012846116 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850200006miniARM82 EUDAMED
- Direct Marketing DI
- 00850012846116 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- L0318 INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE EUDAMED
- GMDN Term
- Surgical instrument assist arm system, manually-adjusted FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
multiSTATION® monoDOC™ RAIL CLAMP by LSI Solutions, Inc. — 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 | 0850200006miniARM82 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- LSI SOLUTIONS, Inc.
- EUDAMED SRN
- US-MF-000008267
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 74a6f755-1545-44f9-bf1b-671933d0d050 61 fields · synced Jun 18, 2026
- FDA UDI 37ba79af-b660-42ad-b3fb-7d0ff2e49a5e 36 fields · synced May 27, 2026