Identity
- Trade Name
- JETi All In One Saline Drive Unit FDA UDI
- Generic Name
- Mechanical atherectomy/thrombectomy drive system FDA UDI
- Model / Reference
- WVSDUP FDA UDI
Identifiers
- Primary DI / UDI-DI
- B139WVSDUP0 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
- Not 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
JETi All In One Saline Drive Unit by Walk Vascular L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Walk Vascular L.l.c.
Sources (1)
- FDA UDI d767acbf-8903-4ff4-a481-c0f572ca3612 33 fields · synced May 30, 2026