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Jaw and Cable Assembly - Articulated Arm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1010937
by Coroneo Inc.
Identity
- Trade Name
- COR-VASC Jaw and Cable Assembly - Articulated Arm FDA UDI
- Generic Name
- Surgical retraction system, reusable FDA UDI
- Device Name
- Jaw and Cable Assembly - Articulated Arm EUDAMEDThe CORVASC coronary artery stabilizers are intended to be used during coronary artery bypass graft surgery to reduce the mobility of cardiac tissue around a targeted graft site on a beating or arrested heart. The Jaw and Cable Assembly is intended to be used with the COR-VASC stabilizers for articulated arm. FDA UDI
- Model / Reference
- 1010937 EUDAMEDFDA UDI
- Description
- The CORVASC coronary artery stabilizers are intended to be used during coronary artery bypass graft surgery to reduce the mobility of cardiac tissue around a targeted graft site on a beating or arrested heart. The Jaw and Cable Assembly is intended to be used with the COR-VASC stabilizers for articulated arm. FDA UDI
Identifiers
- Catalog Number
- 1010937 FDA UDI
- Primary DI / UDI-DI
- D-1010937UL EUDAMED00817121000402 FDA UDI
- Basic UDI-DI
- B-1010937UL 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
- Spain 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
Jaw and Cable Assembly - Articulated Arm 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
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-1010937UL | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-1010937UL | 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 03c7f037-34d1-404f-a7db-5b0364172a5e 61 fields · synced May 31, 2026
- FDA UDI 7bf5bac1-2dfa-4010-b3e0-5c1c4a9a73e0 35 fields · synced May 27, 2026