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Cochlear™ Slim Modiolar Electrode Sheath
FDA UDIClass I (US FDA UDI)
by Cochlear
Identity
- Trade Name
- Cochlear™ Slim Modiolar Electrode Sheath FDA UDI
- Generic Name
- Cochlear electrode array introducer, single-use FDA UDI
- Device Name
- N/A FDA UDI
- Model / Reference
- P1291522 FDA UDI
- Description
- N/A FDA UDI
Identifiers
- Catalog Number
- P1291522 FDA UDI
- Primary DI / UDI-DI
- 09321502043564 FDA UDI
- FDA Product Code
- LRC FDA UDI
- GMDN Term
- Cochlear electrode array introducer, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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
Yes
FDA UDI
Category: Cochlear electrode array introducer, single-use
Cochlear™ Slim Modiolar Electrode Sheath by Cochlear — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Cochlear
Sources (1)
- FDA UDI 19d4425d-9fdc-42b4-96ea-059419db4b04 35 fields · synced May 29, 2026