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SCANLAN® MicroSurgical Instruments
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 3003-202-12
Identity
- Trade Name
- SCANLAN® MicroSurgical Instruments FDA UDI
- Generic Name
- Neurosurgical probe FDA UDI
- Device Name
- SCANLAN® Oretorp Probe EUDAMEDOretorp Probe Blunt FDA UDI
- Model / Reference
- 3003-202-12 EUDAMED4900-01 FDA UDI
- Description
- Oretorp Probe Blunt FDA UDI
Identifiers
- Catalog Number
- 4900-01 FDA UDI
- Primary DI / UDI-DI
- 00846159020342 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159020342 EUDAMED
- FDA Product Code
- GZX FDA UDI
- EMDN Code
- L031102 EXPLORATION PROBES, REUSABLE EUDAMED
- GMDN Term
- Neurosurgical probe FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 882.4525 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 (2)
- FDA UDI a5b7a6e0-5b18-4859-9fab-4fa70e240db3 35 fields · synced Jul 30, 2026
- EUDAMED 4cf7aec0-7cbe-493c-b967-6b1b758e8206 61 fields · synced Jul 30, 2026