Identity
- Trade Name
- EP-4™ FDA UDI
- Generic Name
- Cardiac electrophysiology stimulation system FDA UDI
- Device Name
- Cardiac Stimulator Cardiac Stimulator Cable FDA UDI
- Model / Reference
- 43-1712-0006 FDA UDI
- Description
- Cardiac Stimulator Cardiac Stimulator Cable FDA UDI
Identifiers
- Catalog Number
- 43-1712-0006 FDA UDI
- Primary DI / UDI-DI
- 05415067007865 FDA UDI
- 510(k) Number
- K092913 FDA UDI
- FDA Product Code
- JOQ FDA UDI
- GMDN Term
- Cardiac electrophysiology stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1750 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiac electrophysiology stimulation system
Ep-4™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac electrophysiology stimulation system.
- StimLab — MICROPACE PTY LIMITED · Class II
- Micropace — MICROPACE PTY LIMITED · Class II
- Bloom2 — Fischer Medical · Class II
- ORLAB — MICROPACE PTY LIMITED · Class II
- Bloom2 — Fischer Medical · Class II
- Micropace — MICROPACE PTY LIMITED · Class II
- Bloom2 — Fischer Medical · Class II
- Bloom2 — Fischer Medical · Class II
Cleared under the same submission
K092913 also covers:
- EP-4™ — ST. JUDE MEDICAL, INC.
- EP-4™ — ST. JUDE MEDICAL, INC.
- EP-4™ — ST. JUDE MEDICAL, INC.
- EP-4™ — ST. JUDE MEDICAL, INC.
- EP-4™ — ST. JUDE MEDICAL, INC.
- EP-4™ — ST. JUDE MEDICAL, INC.
- EP-4™ — ST. JUDE MEDICAL, INC.
- EP-4™ — ST. JUDE MEDICAL, INC.
- EP-4™ — ST. JUDE MEDICAL, INC.
- EP-4™ — ST. JUDE MEDICAL, INC.
- WorkMate Claris™ — ST. JUDE MEDICAL, INC.
- WorkMate Claris™ — ST. JUDE MEDICAL, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI 3f695c45-34ec-4efb-a6f7-87ea90060b5a 37 fields · synced Jun 6, 2026