Identity
- Trade Name
- Mi1250 SYNCHRONY 2 FLEXsoft S-Vector Magnet FDA UDI
- Generic Name
- Cochlear implant system electrode array assembly FDA UDI
- Device Name
- Cochlear Implant FDA UDI
- Model / Reference
- 39541 FDA UDI
- Description
- Cochlear Implant FDA UDI
Identifiers
- Catalog Number
- 39569 FDA UDI
- Primary DI / UDI-DI
- 09008737395414 FDA UDI
- PMA Number
- P000025 FDA UDI
- FDA Product Code
- MCM FDA UDI
- GMDN Term
- Cochlear implant system electrode array assembly 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Cochlear implant system electrode array assembly
Mi1250 SYNCHRONY 2 FLEXsoft S-Vector Magnet by Med-El Elektromedizinische Geräte Gesellschaft m.b.H. — Class III — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Cochlear implant system electrode array assembly.
- Cochlear™ Nucleus® Nexa™ cochlear implant with Slim 20 electrode — Cochlear · Class III
- Cochlear™ Nucleus® CI532 cochlear implant with Slim Modiolar electrode — Cochlear · Class III
- Nucleus — Cochlear · Class III
- Nucleus — Cochlear · Class III
- HiRes™ Ultra 3D CI HiFocus™ MS Electrode — Advanced Bionics · Class III
- Cochlear™ Nucleus® CI624 cochlear implant with Slim 20 electrode — Cochlear · Class III
- Nucleus — Cochlear · Class III
- Nucleus — Cochlear · Class III
Cleared under the same submission
P000025 also covers:
- AudioStream, Beige — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- Children's Battery Pack baby pink 12 cm — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- D Coil grey — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- D Coil orange — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- DL-Coil Kit SYNCHRONY black — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- Insertion Electrode Standard — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- Insertion Probe L — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- MAESTRO 8.0 Download — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- Magnet Tool Kit — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- Mi1250 SYNCHRONY 2 COMPRESSED — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- Mi1250 SYNCHRONY 2 PIN FLEXsoft — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- Mini Battery Pack anthracite — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
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
Sources (1)
- FDA UDI 0bcf56f2-3cbf-4df6-a1a4-00a793f6ddcb 37 fields · synced Jun 6, 2026