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SCANLAN® In Situ Valvulotomes
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 3003-366Ref 3003-368
Identity
- Trade Name
- SCANLAN® In Situ Valvulotomes FDA UDISCANLAN® Needle Holders FDA UDI
- Generic Name
- Valvulotome FDA UDISuturing needle holder, reusable FDA UDI
- Device Name
- SCANLAN® In Situ Valvulotome EUDAMEDIn Situ Valvulotome cutting edge FDA UDILEGACY Jacobson Titanium Micro Needle Holder FDA UDIValvulotome FDA UDI
- Model / Reference
- 3003-366 EUDAMEDFDA UDI3003-368 EUDAMED9009-122 FDA UDI9009-123 FDA UDI
- Description
- In Situ Valvulotome cutting edge FDA UDILEGACY Jacobson Titanium Micro Needle Holder FDA UDIValvulotome FDA UDI
Identifiers
- Catalog Number
- 9009-122 FDA UDI3003-366 FDA UDI9009-123 FDA UDI
- Primary DI / UDI-DI
- 00846159010985 EUDAMEDFDA UDI00846159010992 EUDAMEDFDA UDI00846159024098 FDA UDI
- Basic UDI-DI
- B-00846159010985 EUDAMEDB-00846159010992 EUDAMED
- FDA Product Code
- MGZ FDA UDIFHQ FDA UDI
- EMDN Code
- L031102 EXPLORATION PROBES, REUSABLE EUDAMED
- GMDN Term
- Valvulotome FDA UDISuturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass II FDA UDI
- Regulation Number
- 870.4885 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: Valvulotome
SCANLAN® In Situ Valvulotomes by Scanlan International Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Valvulotome.
- PILLING — TELEFLEX INCORPORATED · Class I
- Antegrade and Retrograde LeMills Valvulotome — LeMaitre Vascular, Inc. · Class II
- PILLING — TELEFLEX INCORPORATED · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
- Antegrade and Retrograde LeMills Valvulotome — LeMaitre Vascular, Inc. · Class II
- Over-the-Wire LeMaitre Valvulotome — LeMaitre Vascular, Inc. · Class II
- V. Mueller — STERIS CORPORATION · Class I
- Symmetry Surgical — SYMMETRY SURGICAL INC. · Class II
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 (5)
- FDA UDI decc2587-eaff-47ad-b26f-3aead60caefb 35 fields · synced Sep 17, 2026
- FDA UDI b607ef82-7e59-45f0-9dae-bb7135e29893 35 fields · synced May 30, 2026
- FDA UDI 330d4d97-6a1e-477e-9a7d-209ef732b5ea 35 fields · synced May 30, 2026
- EUDAMED 307930d5-7bdf-42a8-918e-1a413a28a003 61 fields · synced Jul 9, 2026
- EUDAMED 112314ec-4f68-445a-96f0-70842dea8d8a 61 fields · synced Sep 17, 2026