Identity
- Trade Name
- SCANLAN® Needle Holders FDA UDISCANLAN® Dilators FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDIVascular dilator, reusable FDA UDI
- Device Name
- SCANLAN® Malleable Dilator EUDAMEDSCANLAN® Micro Needle Holder FDA UDIMalleable Dilator FDA UDI
- Model / Reference
- 3003-464 EUDAMEDFDA UDIQ99-2.0 FDA UDI
- Description
- SCANLAN® Micro Needle Holder FDA UDIMalleable Dilator FDA UDI
Identifiers
- Catalog Number
- 3003-464 FDA UDIQ99-2.0 FDA UDI
- Primary DI / UDI-DI
- 00846159031386 EUDAMEDFDA UDI00846159003413 FDA UDI
- Basic UDI-DI
- B-00846159031386 EUDAMED
- FDA Product Code
- FHQ FDA UDIDWP FDA UDI
- EMDN Code
- L031102 EXPLORATION PROBES, REUSABLE EUDAMED
- GMDN Term
- Suturing needle holder, reusable FDA UDIVascular dilator, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass II FDA UDI
- Regulation Number
- 876.4730 FDA UDI870.4475 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: Suturing needle holder, reusable
SCANLAN® Needle Holders 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 (3)
- FDA UDI c5399bd7-a994-4ea4-a31b-f26d8cae54c3 35 fields · synced Jun 18, 2026
- FDA UDI 9ef58c98-bda5-40f0-9726-9650f1a39cd7 35 fields · synced May 29, 2026
- EUDAMED 467b9055-5385-473d-958d-1ed66258199e 61 fields · synced Jun 18, 2026