Identity
- Trade Name
- Voss Coronary Bypass Sterile Marker FDA UDI
- Generic Name
- Polymeric coronary bypass marker FDA UDI
- Device Name
- Coronary Bypass Graft Marker (sterile) FDA UDI
- Model / Reference
- 40149 FDA UDI
- Description
- Coronary Bypass Graft Marker (sterile) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811304020041 FDA UDI
- 510(k) Number
- K895369 FDA UDI
- FDA Product Code
- KPK FDA UDI
- GMDN Term
- Polymeric coronary bypass marker FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Polymeric coronary bypass marker
Voss Coronary Bypass Sterile Marker by Vm Cardio Vascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric coronary bypass marker.
- Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal — GENESEE BIOMEDICAL, INC. · Class II
- Scanlan® RADIOMARK® graft markers — SCANLAN INTERNATIONAL INC · Class II
- Scanlan® A/C LOCATOR® graft markers — SCANLAN INTERNATIONAL INC · Class II
- Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal — GENESEE BIOMEDICAL, INC. · Class II
- Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal — GENESEE BIOMEDICAL, INC. · Class II
- SCANLAN® A/C Locator® graft marker — SCANLAN INTERNATIONAL INC · Class II
- Scanlan® RADIOMARK® graft markers — SCANLAN INTERNATIONAL INC · Class II
- Voss Non-Sterile Coronary Bypass Graft Marker — VM CARDIO VASCULAR, INC. · Class II
Cleared under the same submission
K895369 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Vm Cardio Vascular, Inc.
Sources (1)
- FDA UDI 29bb4029-9240-446c-9ed1-32697c90e866 34 fields · synced May 31, 2026