Identity
- Trade Name
- SCANLAN® Ultimate® A/V Punch FDA UDI
- Generic Name
- Aorta punch, single-use FDA UDI
- Device Name
- SCANLAN® Ultimate™ Single-Use Aorta/Vein Punch EUDAMEDSCANLAN® Ultimate® A/V Punch, 5.0 mm FDA UDI
- Model / Reference
- 1001-626 EUDAMEDFDA UDI
- Description
- SCANLAN® Ultimate® A/V Punch, 5.0 mm FDA UDI
Identifiers
- Catalog Number
- 1001-626 FDA UDI
- Primary DI / UDI-DI
- 00846159000191 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159000191 EUDAMED
- FDA Product Code
- KDC FDA UDI
- EMDN Code
- C01901201 AORTIC PUNCHES EUDAMED
- GMDN Term
- Aorta punch, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Category: Aorta punch, single-use
SCANLAN® Ultimate® A/V Punch by Scanlan International Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Aorta punch, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Scanlan International Inc
Sources (2)
- FDA UDI e49359dc-7de3-4ea0-87d4-76fb76232045 35 fields · synced Jul 28, 2026
- EUDAMED 9be9d1dc-21a5-43a7-bf8b-273b5e0b4f7f 61 fields · synced Jul 28, 2026