Identity
- Trade Name
- IBC Aortic Punch, Long, 4.4mm FDA UDI
- Generic Name
- Aorta punch, single-use FDA UDI
- Device Name
- The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis. FDA UDI
- Model / Reference
- APL44 FDA UDI
- Description
- The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10814321020244 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
- Not 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
IBC Aortic Punch, Long, 4.4mm by Movair, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Movair, Inc.
Sources (1)
- FDA UDI bf2b087b-e904-4d93-94f6-8328ef014be9 34 fields · synced May 30, 2026