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® MEMORY Garrett Vascular Dilator EUDAMEDJacobson Micro Needle Holder Flat Handle FDA UDIMemory Garrett Vascular Dilator FDA UDI
- Model / Reference
- 3003-249 EUDAMEDFDA UDI8008-476 FDA UDI
- Description
- Jacobson Micro Needle Holder Flat Handle FDA UDIMemory Garrett Vascular Dilator FDA UDI
Identifiers
- Catalog Number
- 3003-249 FDA UDI8008-476 FDA UDI
- Primary DI / UDI-DI
- 00846159025095 EUDAMEDFDA UDI00846159019223 FDA UDI
- Basic UDI-DI
- B-00846159025095 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 84076e58-e7c4-446c-91e8-d45b80812bba 35 fields · synced Sep 17, 2026
- FDA UDI 4abdb0f2-c214-4441-91ca-c4cc94ffd247 35 fields · synced May 30, 2026
- EUDAMED 20a229e8-2d50-4eff-a98d-839758381666 61 fields · synced Sep 17, 2026