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SCANLAN® MicroSurgical Instruments
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 3003-352
Identity
- Trade Name
- SCANLAN® MicroSurgical Instruments FDA UDISCANLAN® Needle Holders FDA UDI
- Generic Name
- Neurosurgical probe FDA UDISuturing needle holder, reusable FDA UDI
- Device Name
- SCANLAN® Olivecrona Double Ended Dissector EUDAMEDSCANLAN® LEGACY Jacobson Titanium Micro Needle Holder EUDAMEDDouble Ended Dissector without Ligature Guide FDA UDILEGACY Jacobson Titanium Micro Needle Holder FDA UDI
- Model / Reference
- 3003-352 EUDAMEDFDA UDI9009-104 FDA UDI
- Description
- Double Ended Dissector without Ligature Guide FDA UDILEGACY Jacobson Titanium Micro Needle Holder FDA UDI
Identifiers
- Catalog Number
- 9009-104 FDA UDI3003-352 FDA UDI
- Primary DI / UDI-DI
- 00846159021141 EUDAMEDFDA UDI00846159031591 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159021141 EUDAMEDB-00846159031591 EUDAMED
- FDA Product Code
- GZX FDA UDIFHQ FDA UDI
- EMDN Code
- L031102 EXPLORATION PROBES, REUSABLE EUDAMEDL0205 NEEDLE HOLDERS, REUSABLE EUDAMED
- GMDN Term
- Neurosurgical probe FDA UDISuturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 882.4525 FDA UDI876.4730 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: Neurosurgical probe
SCANLAN® MicroSurgical Instruments 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 4b6a4c3c-0e1d-436a-b71c-dcfa8d474354 35 fields · synced Jul 15, 2026
- FDA UDI 4fcfb42b-da10-436e-817e-ea75e1206737 35 fields · synced May 30, 2026
- EUDAMED d820d92b-e9a0-4be5-8b32-091c83e7e3e6 61 fields · synced Jul 13, 2026
- EUDAMED 1e40d9b5-54f5-479c-a58d-f25fc861c9b2 61 fields · synced Jul 15, 2026