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SCANLAN® MicroSurgical Instruments
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 3003-358
Identity
- Trade Name
- SCANLAN® MicroSurgical Instruments FDA UDI
- Generic Name
- Open-surgery dissector FDA UDI
- Device Name
- SCANLAN® Olivecrona Double Ended Dissector EUDAMEDOLIVECRONA DOUBLE ENDED DISSECTOR DELICATE 9 3/4" / 24.2CM FDA UDI
- Model / Reference
- 3003-358 EUDAMED9009-108 FDA UDI
- Description
- OLIVECRONA DOUBLE ENDED DISSECTOR DELICATE 9 3/4" / 24.2CM FDA UDI
Identifiers
- Catalog Number
- 9009-108 FDA UDI
- Primary DI / UDI-DI
- 00846159032635 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159032635 EUDAMED
- FDA Product Code
- GDI FDA UDI
- EMDN Code
- L031102 EXPLORATION PROBES, REUSABLE EUDAMED
- GMDN Term
- Open-surgery dissector FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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: Open-surgery dissector
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 f076ba1f-40ed-4b7a-988e-fa128da83538 35 fields · synced Jul 24, 2026
- EUDAMED 4d5c2ebb-983f-45a1-9b5f-622d5015a41e 61 fields · synced Jul 24, 2026