Identity
- Trade Name
- HiRes™ Ultra Magnet Pusher Tool FDA UDI
- Generic Name
- ENT surgical procedure kit, non-medicated, reusable FDA UDI
- Model / Reference
- CI-4349 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840094456372 FDA UDI
- PMA Number
- P960058 FDA UDI
- FDA Product Code
- MCM FDA UDI
- GMDN Term
- ENT surgical procedure kit, non-medicated, reusable 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: ENT surgical procedure kit, non-medicated, reusable
HiRes™ Ultra Magnet Pusher Tool by Advanced Bionics — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Bionics
Sources (1)
- FDA UDI a4b16f8d-25a9-48db-b5ae-2d7220606e8b 34 fields · synced May 30, 2026