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Articluated arm clamp base
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1011593
by Coroneo Inc.
Identity
- Trade Name
- COR-VASC Articulated Arm Clamp Base FDA UDI
- Generic Name
- Surgical retraction system, reusable FDA UDI
- Device Name
- Articluated arm clamp base EUDAMEDThe COR-VASC system is intended to be used for performing coronary artery bypass surgery on a beating or arrested heart. The Articulated Arm Clamp Base is intended to be used together with the Articulated Arm components 1011592 and 1010937. FDA UDI
- Model / Reference
- 1011593 EUDAMEDFDA UDI
- Description
- The COR-VASC system is intended to be used for performing coronary artery bypass surgery on a beating or arrested heart. The Articulated Arm Clamp Base is intended to be used together with the Articulated Arm components 1011592 and 1010937. FDA UDI
Identifiers
- Catalog Number
- 1011593 FDA UDI
- Primary DI / UDI-DI
- D-1011593UH EUDAMED00817121000426 FDA UDI
- Basic UDI-DI
- B-1011593UH EUDAMED
- FDA Product Code
- DWS FDA UDI
- EMDN Code
- L0899 THORACIC SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical retraction system, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 870.4500 FDA UDI
- Market of Registration
- Portugal 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Articluated arm clamp base by Coroneo Inc — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-1011593UH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Coroneo Inc.
- EUDAMED SRN
- CA-MF-000019141
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED d8988016-53fc-471a-bd05-5cd293fe3a74 61 fields · synced Jul 28, 2026
- FDA UDI 9e2420e2-7ade-479b-aba8-e1cbac2a0b76 35 fields · synced May 30, 2026