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SCANLAN® MicroSurgical Instruments
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 3003-200
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® Nelms Suction Elevator EUDAMEDNelms Suction Elevator Cottle Style Sharp Ended FDA UDIJacobson Micro Needle Holder Round Handle FDA UDI
- Model / Reference
- 3003-200 EUDAMEDFDA UDI4004-120 FDA UDI
- Description
- Nelms Suction Elevator Cottle Style Sharp Ended FDA UDIJacobson Micro Needle Holder Round Handle FDA UDI
Identifiers
- Catalog Number
- 4004-120 FDA UDI3003-200 FDA UDI
- Primary DI / UDI-DI
- 00846159027877 EUDAMEDFDA UDI00846159002942 FDA UDI
- Basic UDI-DI
- B-00846159027877 EUDAMED
- FDA Product Code
- GZX FDA UDIFHQ FDA UDI
- EMDN Code
- L031102 EXPLORATION PROBES, 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 (3)
- FDA UDI a940bc8a-6a28-4fb1-8baa-0d45c83209eb 35 fields · synced Jul 21, 2026
- FDA UDI c8ff4e47-106d-4be6-8910-2979f1c232dc 35 fields · synced May 30, 2026
- EUDAMED 61561f66-72b2-4102-a272-287d9ba610c3 61 fields · synced Jul 21, 2026