Identity
- Trade Name
- Axonics FDA UDI
- Generic Name
- Personal device holder, reusable FDA UDI
- Device Name
- Curved Charging Belt - Regular FDA UDI
- Model / Reference
- 9108-R FDA UDI
- Description
- Curved Charging Belt - Regular FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10810005340424 FDA UDI
- FDA Product Code
- EZW FDA UDIQON FDA UDI
- GMDN Term
- Personal device holder, reusable FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 876.5270 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
Category: Personal device holder, reusable
Axonics by Axonics Modulation Technologies, Inc. — 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 |
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Manufacturer
- Manufacturer
- Axonics Modulation Technologies, Inc.
Sources (1)
- FDA UDI 94a05e28-ff25-4924-b95c-b625a6e90c57 33 fields · synced May 30, 2026