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COR-VALV, Artial tissue retractor system
FDA UDIEUDAMEDClass I (US FDA UDI)
by Coroneo Inc
Identity
- Trade Name
- COR-VALV, Artial tissue retractor system FDA UDI
- Generic Name
- Surgical retraction system, reusable FDA UDI
- Device Name
- The COR-VALV Atrial retractor system is intended to retract atrial tissue during repair of replacement of the mitral cardiac valve. The system consists of a sternum retractor, a clamping apparatus, and an adjustable atrial retractor. FDA UDI
- Model / Reference
- 1100041 FDA UDI
- Description
- The COR-VALV Atrial retractor system is intended to retract atrial tissue during repair of replacement of the mitral cardiac valve. The system consists of a sternum retractor, a clamping apparatus, and an adjustable atrial retractor. FDA UDI
Identifiers
- Catalog Number
- 1100041 FDA UDI
- Primary DI / UDI-DI
- 10817121000492 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Surgical retraction system, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical retraction system, reusable
COR-VALV, Artial tissue retractor system by Coroneo Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical retraction system, reusable.
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- Thompson — Thompson Surgical Instruments · Class I
- Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INC · Class I
- Thompson — Thompson Surgical Instruments · Class I
- Thompson — Thompson Surgical Instruments · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Coroneo Inc
Sources (2)
- FDA UDI 4ba6959f-0c8c-4f86-8010-a3a22797833a 35 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced May 29, 2026