Identity
- Trade Name
- Axonics FDA UDI
- Generic Name
- Implantable incontinence-control electrical stimulation system programmer, line-powered FDA UDI
- Device Name
- Clinician Programmer FDA UDI
- Model / Reference
- 1501 FDA UDI
- Description
- Clinician Programmer FDA UDI
Identifiers
- Catalog Number
- 1501 FDA UDI
- Primary DI / UDI-DI
- 10810005340028 FDA UDI
- PMA Number
- P190006 FDA UDI
- FDA Product Code
- EZW FDA UDI
- GMDN Term
- Implantable incontinence-control electrical stimulation system programmer, line-powered 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Implantable incontinence-control electrical stimulation system programmer, line-powered
Axonics by Axonics Modulation Technologies, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P190006 also covers:
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 eb85837c-a7e8-4871-bb9c-47695cf8a881 36 fields · synced May 30, 2026