Articulated arm clamping system
EUDAMEDFDA UDIClass IIa (EU MDR)
by Coroneo Inc.
Identity
- Trade Name
- COR-VASC Articulated arm clamping system FDA UDI
- Generic Name
- Surgical retraction system, reusable FDA UDI
- Device Name
- Articulated arm clamping system EUDAMEDThe device is intended to be used to clamp coronary artery stabilizers manufactured by CORONEO INC to the adult thoracic retractors manufactured by CORONEO INC. FDA UDI
- Model / Reference
- 1100349 EUDAMEDFDA UDI
- Description
- The device is intended to be used to clamp coronary artery stabilizers manufactured by CORONEO INC to the adult thoracic retractors manufactured by CORONEO INC. FDA UDI
Identifiers
- Catalog Number
- 1100349 FDA UDI
- Primary DI / UDI-DI
- D-1100349TX EUDAMED00817121000433 FDA UDI
- Basic UDI-DI
- B-1100349TX 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
An articulated arm clamping system is a medical device used to immobilize and stabilize the arm, particularly in orthopedic surgery. This device is designed for use in hospitals and clinics, where it can be used to immobilize patients' arms during surgical procedures.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-1100349TX | 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 256fea69-e353-45a8-9913-dfb436aef0d2 61 fields · synced Jul 23, 2026
- FDA UDI a1e59ec6-0c81-4ea4-9057-0cabb1751a08 35 fields · synced May 30, 2026