← Back to catalogue
COR-VALV Atrial tissue retractor system
FDA UDIClass I (US FDA UDI)
by Coroneo Inc
Identity
- Trade Name
- COR-VALV Atrial 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 or replacement of the mitral cardiac valve. The system consists or a large adult sternum retractor, a clamping apparatus, and an adjustable atrial tissue retractor. FDA UDI
- Model / Reference
- 1100042 FDA UDI
- Description
- The COR-VALV Atrial retractor system is intended to retract atrial tissue during repair or replacement of the mitral cardiac valve. The system consists or a large adult sternum retractor, a clamping apparatus, and an adjustable atrial tissue retractor. FDA UDI
Identifiers
- Catalog Number
- 1100042 FDA UDI
- Primary DI / UDI-DI
- 10817121000508 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 Atrial tissue retractor system by Coroneo Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retraction system, reusable.
- 45930R — Thompson Surgical Instruments, Inc. · Class IIa
- Sigma — ALPHATEC SPINE, INC. · Class I
- Omni-Tract® — Integra Lifesciences Corp. · Class I
- Drills and Handpieces — SOUTHERN IMPLANTS (PTY) LTD · Class IIa
- 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coroneo Inc
Sources (1)
- FDA UDI 538e1612-1858-4bc4-9252-85113ac2ac88 35 fields · synced May 30, 2026