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® Special Vasculator Dilator EUDAMEDSCANLAN® Richards Micro Needle Holder EUDAMEDRichards Micro Needle Holder FDA UDISpecial Vasculator Dilator FDA UDI
- Model / Reference
- 3003-450 EUDAMEDFDA UDI9099-74 FDA UDI
- Description
- Richards Micro Needle Holder FDA UDISpecial Vasculator Dilator FDA UDI
Identifiers
- Catalog Number
- 3003-450 FDA UDI9099-74 FDA UDI
- Primary DI / UDI-DI
- 00846159003376 EUDAMEDFDA UDI00846159031508 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159031508 EUDAMEDB-00846159003376 EUDAMED
- FDA Product Code
- FHQ FDA UDIDWP FDA UDI
- EMDN Code
- L031102 EXPLORATION PROBES, REUSABLE EUDAMEDL0205 NEEDLE HOLDERS, 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 (4)
- FDA UDI cc2ab53b-9a22-466d-bb6d-644ded6f0028 35 fields · synced Sep 17, 2026
- FDA UDI a49ceac6-c54b-439e-bd1d-0a379e3df20d 35 fields · synced May 30, 2026
- EUDAMED 24a7ef9b-6192-4782-ba9d-81ff2b75c92d 61 fields · synced Aug 2, 2026
- EUDAMED 3ba6d87d-ef34-452e-afa0-dd22d2501413 61 fields · synced Sep 17, 2026