Identity
- Trade Name
- FARASTAR™ FDA UDI
- Generic Name
- Cardiac irreversible electroporation system generator FDA UDI
- Device Name
- Recording System Module FDA UDI
- Model / Reference
- M004PF61M427R FDA UDI
- Description
- Recording System Module FDA UDI
Identifiers
- Catalog Number
- M004PF61M427R FDA UDI
- Primary DI / UDI-DI
- 00191506043803 FDA UDI
- PMA Number
- P230030 FDA UDI
- FDA Product Code
- QZI FDA UDI
- GMDN Term
- Cardiac irreversible electroporation system generator FDA UDI
Classification
- Device Class
- Class III 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: Cardiac irreversible electroporation system generator
Farastar™ by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac irreversible electroporation system generator.
- TRUPULSE™ Generator — Biosense Webster Inc · Class III
- HexaPulse™ PF Generator — MEDTRONIC, INC. · Class III
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- Globe® PF Generator — Kardium, Inc. · Class III
- PulseSelect™ — MEDTRONIC, INC. · Class III
- FARASTAR™ — Boston Scientific · Class III
- FARASTAR™ — Boston Scientific · Class III
Cleared under the same submission
P230030 also covers:
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
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
- Boston Scientific
Sources (1)
- FDA UDI 3c880e5b-1607-4790-9b3d-8330db9251e8 35 fields · synced May 30, 2026