Identity
- Trade Name
- Intra-Art Coronary Artery Retraction Clip FDA UDI
- Generic Name
- Coronary artery exposure retractor FDA UDI
- Device Name
- Coronary Artery Retraction Clip FDA UDI
- Model / Reference
- CRC-5 FDA UDI
- Description
- Coronary Artery Retraction Clip FDA UDI
Identifiers
- Primary DI / UDI-DI
- B040CRC51 FDA UDI
- 510(k) Number
- K882981 FDA UDI
- FDA Product Code
- DWS FDA UDI
- GMDN Term
- Coronary artery exposure retractor FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 5 Millimeter FDA UDI
Category: Coronary artery exposure retractor
Intra-Art Coronary Artery Retraction Clip by Genesee Biomedical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K882981 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 I | Pending data |
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Manufacturer
- Manufacturer
- Genesee Biomedical, Inc.
Sources (1)
- FDA UDI f3edbd45-b216-4168-9029-0e751fe96067 36 fields · synced May 30, 2026