multiSTATION® RITA RetroSterno™ FLAT PADDLE
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- multiSTATION® RITA RetroSterno™ FLAT PADDLE EUDAMEDminiARM® multiSTATION™ System FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- multiSTATION® SubX™ STERNAL ASCENDER™ SYSTEM EUDAMEDRIMA RetroSterno™ PADDLE FDA UDI
- Model / Reference
- 080900 EUDAMED081241 EUDAMEDFDA UDI
- Description
- RIMA RetroSterno™ PADDLE FDA UDI
Identifiers
- Catalog Number
- 081241 FDA UDI
- Primary DI / UDI-DI
- 00850012846178 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850200006miniARM82 EUDAMED
- Direct Marketing DI
- 00850012846178 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- L03140199 SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical retractor/retraction system blade, reusable 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
Single Use
No
Implantable
No
Reusable
Yes
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
Yes
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
No
Category: Hand-held surgical retractor, reusable
multiSTATION® RITA RetroSterno™ FLAT PADDLE by LSI Solutions, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 6ad445ec-245f-4ef0-a8c8-cac1a23517bf 61 fields · synced Jul 11, 2026
- FDA UDI e805884a-ce1a-4ff6-b4e0-93150e37e93c 36 fields · synced May 24, 2026