Identity
- Trade Name
- SCANLAN® Dilators FDA UDISCANLAN® Needle Holders FDA UDI
- Generic Name
- Vascular dilator, reusable FDA UDISuturing needle holder, reusable FDA UDI
- Device Name
- SCANLAN® Garrett Vascular Dilator EUDAMEDSCANLAN® Cardiovascular Needle Holder EUDAMEDGarrett Vascular Dilator FDA UDICardiovascular Needle Holder Diamond Dust™ FDA UDI
- Model / Reference
- 3003-436 EUDAMEDFDA UDI9009-86 FDA UDI
- Description
- Garrett Vascular Dilator FDA UDICardiovascular Needle Holder Diamond Dust™ FDA UDI
Identifiers
- Catalog Number
- 9009-86 FDA UDI3003-436 FDA UDI
- Primary DI / UDI-DI
- 00846159010732 EUDAMEDFDA UDI00846159003338 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159010732 EUDAMEDB-00846159003338 EUDAMED
- FDA Product Code
- DWP FDA UDIFHQ FDA UDI
- EMDN Code
- L031102 EXPLORATION PROBES, REUSABLE EUDAMEDL0205 NEEDLE HOLDERS, REUSABLE EUDAMED
- GMDN Term
- Vascular dilator, reusable FDA UDISuturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass II FDA UDI
- Regulation Number
- 870.4475 FDA UDI876.4730 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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 dilator, reusable
SCANLAN® Dilators by Scanlan International Inc — Class II — 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Scanlan International Inc
Sources (4)
- FDA UDI 11d1ae9f-bc46-4de8-92f9-c51946d7538f 35 fields · synced Jul 30, 2026
- FDA UDI 9c93bfee-20a5-42f7-91be-b5b77759575a 35 fields · synced May 30, 2026
- EUDAMED c666cfa9-614e-4877-b5b8-9a175046ae43 61 fields · synced Jul 27, 2026
- EUDAMED 6bee7ba4-5823-4bd0-ac57-d2f1474fb203 61 fields · synced Jul 30, 2026