Identity
- Trade Name
- Eze-Sit® Valvulotome EUDAMEDEze-Sit Valvulotome FDA UDI
- Generic Name
- Valvulotome, percutaneous FDA UDI
- Device Name
- Eze-Sit Valvulotome EUDAMEDEze-Sit Valvulotome Overall product length- 94cm Usable/ effective length- 91cm FDA UDI
- Model / Reference
- TIVK2030M EUDAMED94cm FDA UDI
- Description
- Eze-Sit Valvulotome Overall product length- 94cm Usable/ effective length- 91cm FDA UDI
Identifiers
- Catalog Number
- TIVK2030 FDA UDI
- Primary DI / UDI-DI
- 00840663112197 EUDAMED00840663102297 FDA UDI
- Basic UDI-DI
- 08406631EZESITKX EUDAMED
- FDA Product Code
- MGZ FDA UDI
- EMDN Code
- C019017 VALVULOTOMES, SINGLE-USE EUDAMED
- GMDN Term
- Valvulotome, percutaneous FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4885 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Shaft Length — 94 Centimeter FDA UDI
Category: ValvulotomeValvulotome, percutaneous
Eze-Sit Valvulotome by LeMaitre Vascular, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Valvulotome, percutaneous.
- LimFlow Vector — Limflow Inc. · Class II
- LimFlow Vector — Limflow Inc. · Class II
- Boomerang — Aveera Medical, Inc. · Class II
- Boomerang — Aveera Medical, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- LeMaitre Vascular, Inc.
Sources (2)
- FDA UDI f99edcc0-b09b-4679-bd58-35b2c1deef3c 35 fields · synced Jul 26, 2026
- EUDAMED 064ad485-c995-494f-a45d-4e2ad405be58 61 fields · synced Jul 26, 2026