Identity
- Trade Name
- SCANLAN® Needle Holders FDA UDISCANLAN® MicroSurgical Instruments FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDIOpen-surgery dissector FDA UDI
- Device Name
- SCANLAN® Olivecrona Double Ended Dissector EUDAMEDSCANLAN® LEGACY Jacobson Titanium Micro Needle Holder EUDAMEDLEGACY Jacobson Titanium Micro Needle Holder FDA UDIOlivecrona Double-Ended Dissector Regular 9-1/2" / 24.1 cm FDA UDI
- Model / Reference
- 3003-362 EUDAMEDFDA UDI9009-110 FDA UDI
- Description
- LEGACY Jacobson Titanium Micro Needle Holder FDA UDIOlivecrona Double-Ended Dissector Regular 9-1/2" / 24.1 cm FDA UDI
Identifiers
- Catalog Number
- 3003-362 FDA UDI9009-110 FDA UDI
- Primary DI / UDI-DI
- 00846159024074 EUDAMEDFDA UDI00846159032642 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159032642 EUDAMEDB-00846159024074 EUDAMED
- FDA Product Code
- FHQ FDA UDIGDI FDA UDI
- EMDN Code
- L031102 EXPLORATION PROBES, REUSABLE EUDAMEDL0205 NEEDLE HOLDERS, REUSABLE EUDAMED
- GMDN Term
- Suturing needle holder, reusable FDA UDIOpen-surgery dissector FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.4730 FDA UDI878.4800 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 e09a7a0a-a241-4c25-ba95-ad5f7d13ff31 35 fields · synced Aug 1, 2026
- FDA UDI d9fa4271-f451-4628-815f-3db7800e3737 35 fields · synced May 29, 2026
- EUDAMED fa3da2af-2a47-4391-9fc6-bb2dfeea666a 61 fields · synced Jun 18, 2026
- EUDAMED b8e43150-7741-4299-8409-f2073db8b5fc 61 fields · synced Aug 1, 2026