Identity
- Trade Name
- Epsila EV™ FDA UDI
- Generic Name
- Pacing/defibrillation lead tunneller FDA UDI
- Device Name
- TOOL EAZ101 TUNNELING ZONE 1 FDA UDI
- Model / Reference
- EAZ101 FDA UDI
- Description
- TOOL EAZ101 TUNNELING ZONE 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000369736 FDA UDI
- PMA Number
- P220012 FDA UDI
- FDA Product Code
- NVY FDA UDILWS FDA UDI
- GMDN Term
- Pacing/defibrillation lead tunneller FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pacing/defibrillation lead tunneller
Epsila EV™ by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pacing/defibrillation lead tunneller.
- EMBLEM™ S-ICD Electrode Delivery System — Boston Scientific · Class III
- Epsila EV™ — MEDTRONIC, INC. · Class III
Cleared under the same submission
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 III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 05513c7d-38ca-4287-931f-06249888d785 36 fields · synced May 30, 2026