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® Vascular Graduated Dilators EUDAMEDSCANLAN® Cardiovascular Needle Holder EUDAMEDVascular Graduated Dilator FDA UDICardiovascular Needle Holder Diamond Dust™ FDA UDI
- Model / Reference
- 3003-442 EUDAMEDFDA UDI9009-92 FDA UDI
- Description
- Vascular Graduated Dilator FDA UDICardiovascular Needle Holder Diamond Dust™ FDA UDI
Identifiers
- Catalog Number
- 9009-92 FDA UDI3003-442 FDA UDI
- Primary DI / UDI-DI
- 00846159031492 EUDAMEDFDA UDI00846159003369 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159031492 EUDAMEDB-00846159003369 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 151071e0-5d42-404d-942c-41d5b5ecdff6 35 fields · synced Jul 14, 2026
- FDA UDI e25f65ab-e8cf-40bb-a4f4-924a056ebf74 35 fields · synced May 30, 2026
- EUDAMED 842e4ffd-b0da-4a39-9cca-847818b3fc6e 61 fields · synced Jul 12, 2026
- EUDAMED bc0eea19-efae-4369-b308-2376f3fbd4a3 61 fields · synced Jul 14, 2026