Identity
- Trade Name
- SCANLAN® In Situ Valvulotomes FDA UDI
- Generic Name
- Valvulotome FDA UDI
- Device Name
- SCANLAN® Valvutome EUDAMEDValvulotome FDA UDI
- Model / Reference
- 3003-374 EUDAMED9009-125 FDA UDI
- Description
- Valvulotome FDA UDI
Identifiers
- Catalog Number
- 9009-125 FDA UDI
- Primary DI / UDI-DI
- 00846159032000 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159032000 EUDAMED
- FDA Product Code
- MGZ FDA UDI
- EMDN Code
- L031102 EXPLORATION PROBES, REUSABLE EUDAMED
- GMDN Term
- Valvulotome FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4885 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: Valvulotome
SCANLAN® In Situ Valvulotomes by Scanlan International Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Valvulotome.
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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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Scanlan International Inc
Sources (2)
- FDA UDI 87d19d7d-bd04-4890-b83c-f33c3e0c823f 35 fields · synced Jul 14, 2026
- EUDAMED 62b12fc6-bd47-4837-ae40-02a9633140ad 61 fields · synced Jul 14, 2026