Identity
- Trade Name
- CleanCut Rotating Aortic Punch FDA UDI
- Generic Name
- Aorta punch, single-use FDA UDI
- Device Name
- Aortic Punches are used to create a uniform opening in blood vessels during cardiovascular surgery. The vessel graft is inserted into the created opening and sutured to the vessel wall. Aortic Lancets are used to make a small uniform cut in a blood vessel to facilitate insertion of an aortic punch. Punches come in various lengths, diameters and tip configurations. FDA UDI
- Model / Reference
- RCL40 FDA UDI
- Description
- Aortic Punches are used to create a uniform opening in blood vessels during cardiovascular surgery. The vessel graft is inserted into the created opening and sutured to the vessel wall. Aortic Lancets are used to make a small uniform cut in a blood vessel to facilitate insertion of an aortic punch. Punches come in various lengths, diameters and tip configurations. FDA UDI
Identifiers
- Catalog Number
- RCL40 FDA UDI
- Primary DI / UDI-DI
- 10634624374000 FDA UDI
- FDA Product Code
- DWS FDA UDI
- GMDN Term
- Aorta punch, single-use 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Aorta punch, single-use
CleanCut Rotating Aortic Punch by Quest Medical Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- SCANLAN® A/V Punch — SCANLAN INTERNATIONAL INC · 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 |
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Manufacturer
- Manufacturer
- Quest Medical Inc
Sources (1)
- FDA UDI 64067912-463c-4e69-9d12-1763eaa0300e 34 fields · synced Jun 6, 2026