Identity
- Trade Name
- WovenFlexie™ FDA UDI
- Generic Name
- Intracardiac electrode FDA UDI
- Device Name
- Diagnostic Electrode Catheter FDA UDI
- Model / Reference
- M0045FMC007130 FDA UDI
- Description
- Diagnostic Electrode Catheter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729901129 FDA UDI
- FDA Product Code
- DRF FDA UDI
- GMDN Term
- Intracardiac electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1220 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intracardiac electrode
WovenFlexie™ by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intracardiac electrode.
- OSTEON II — Genoss · Class II
- Woven — Boston Scientific · Class II
- Dynamic Tip™ — Boston Scientific · Class II
- EP XT™ — Boston Scientific · Class II
- WovenFlexie™ — Boston Scientific · Class II
- Dynamic XT™ — Boston Scientific · Class II
- WovenFlexie™ — Boston Scientific · Class II
- Dynamic XT™ — Boston Scientific · 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
- Boston Scientific
Sources (1)
- FDA UDI 09303966-2898-4a90-8b03-5fa3e0e38c00 34 fields · synced Jun 8, 2026