Identity
- Trade Name
- SCANLAN® Tunnelers FDA UDI
- Generic Name
- Vascular graft tunneller FDA UDI
- Device Name
- SCANLAN® A/V Access Tunneler EUDAMEDA/V Access Tunneler FDA UDI
- Model / Reference
- 9009-14 EUDAMEDFDA UDI
- Description
- A/V Access Tunneler FDA UDI
Identifiers
- Catalog Number
- 9009-14 FDA UDI
- Primary DI / UDI-DI
- 00846159023589 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159023589 EUDAMED
- FDA Product Code
- DWS FDA UDI
- EMDN Code
- C019010 INTRAVASCULAR RECANALISATION SYSTEMS EUDAMED
- GMDN Term
- Vascular graft tunneller FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 870.4500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Vascular graft tunneller
SCANLAN® Tunnelers by Scanlan International Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 19608515-1732-4ace-89b1-53b39250bc55 35 fields · synced Jun 19, 2026
- EUDAMED 527529f2-31d8-459d-b181-2d5d17ba56b6 61 fields · synced Jun 19, 2026