Identity
- Trade Name
- JETi™ FDA UDI
- Generic Name
- Mechanical atherectomy/thrombectomy drive system FDA UDI
- Device Name
- JETi™ Saline Drive Unit FDA UDI
- Model / Reference
- WVSDUP FDA UDI
- Description
- JETi™ Saline Drive Unit FDA UDI
Identifiers
- Catalog Number
- WVSDUP FDA UDI
- Primary DI / UDI-DI
- 08717648351365 FDA UDI
- FDA Product Code
- QEZ FDA UDI
- GMDN Term
- Mechanical atherectomy/thrombectomy drive system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mechanical atherectomy/thrombectomy drive system
JETi™ by Abbott Vascular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical atherectomy/thrombectomy drive system.
- Drive System (Straub Medical®) — Straub Medical AG · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Abbott Vascular
Sources (1)
- FDA UDI c5faf3d1-8e23-4a21-aeb1-a2e7beaa35ba 37 fields · synced May 30, 2026