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SCANLAN® Vascular Tunneler Sheaths and Bullet Tips
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 9009-20
Identity
- Trade Name
- SCANLAN® Vascular Tunneler Sheaths and Bullet Tips FDA UDI
- Generic Name
- Vascular graft tunneller FDA UDI
- Device Name
- SCANLAN® A/V Access Tunneler Sheaths and Bullet Tips EUDAMEDLarge (orange) for grafts up to 8 mm, 12" / 30.5 cm (1/pkg) FDA UDI
- Model / Reference
- 9009-20 EUDAMEDFDA UDI
- Description
- Large (orange) for grafts up to 8 mm, 12" / 30.5 cm (1/pkg) FDA UDI
Identifiers
- Catalog Number
- 9009-20 FDA UDI
- Primary DI / UDI-DI
- 00846159000993 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159000993 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
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: Vascular graft tunneller
SCANLAN® Vascular Tunneler Sheaths and Bullet Tips by Scanlan International Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Vascular graft tunneller.
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- SURGIPROS — SURGIPROS LLC · Class I
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 30de62f7-f254-4694-bf70-4934bbf5fd08 35 fields · synced Jun 19, 2026
- EUDAMED 3b35ede4-8e3b-4da4-92a8-5e3313523881 61 fields · synced Jun 19, 2026