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® Garrett Vascular Dilators EUDAMEDSCANLAN® Microvascular Needle Holder EUDAMEDMicrovascular Needle Holder Diamond Dust™ Jaw FDA UDIGarrett Vascular Dilator FDA UDI
- Model / Reference
- 3003-428 EUDAMEDFDA UDI9009-76 FDA UDI
- Description
- Microvascular Needle Holder Diamond Dust™ Jaw FDA UDIGarrett Vascular Dilator FDA UDI
Identifiers
- Catalog Number
- 3003-428 FDA UDI9009-76 FDA UDI
- Primary DI / UDI-DI
- 00846159003291 EUDAMEDFDA UDI00846159010688 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159010688 EUDAMEDB-00846159003291 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 eeb6fe53-dc49-4d12-9192-c9c72826bcab 35 fields · synced Jul 15, 2026
- FDA UDI c734a4bd-c9b2-4276-b780-dc7ac4b6d2bf 35 fields · synced May 29, 2026
- EUDAMED a56ab1c1-bae3-4a8c-95b3-bedb2932543d 61 fields · synced Jun 18, 2026
- EUDAMED 586bbe7c-dda3-4ed3-8e96-86839522a2e4 61 fields · synced Jul 15, 2026