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 Dilators EUDAMEDSCANLAN® DeBakey Needle Holder EUDAMEDGarrett Vascular Dilator FDA UDIDeBakey Needle Holder Diamond Dust™ Jaw FDA UDI
- Model / Reference
- 3003-414 EUDAMEDFDA UDI9009-64 FDA UDI
- Description
- Garrett Vascular Dilator FDA UDIDeBakey Needle Holder Diamond Dust™ Jaw FDA UDI
Identifiers
- Catalog Number
- 9009-64 FDA UDI3003-414 FDA UDI
- Primary DI / UDI-DI
- 00846159010633 EUDAMEDFDA UDI00846159003239 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159010633 EUDAMEDB-00846159003239 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 be1aaffd-3dd7-41b8-815f-293c30838307 35 fields · synced Jul 16, 2026
- FDA UDI 2d0065c2-2b9f-469a-998b-bc2fe2537fd8 35 fields · synced May 30, 2026
- EUDAMED 51665b68-f792-4332-b6cc-eaf53e5542ed 61 fields · synced Jul 9, 2026
- EUDAMED 1fec1ad4-d0fd-4e68-8a8f-03787a9582cc 61 fields · synced Jul 16, 2026