Identity
- Trade Name
- Senza FDA UDI
- Generic Name
- Personal device holder, single-use FDA UDI
- Device Name
- TSM Pouch Kit FDA UDI
- Model / Reference
- ACCK4310 FDA UDI
- Description
- TSM Pouch Kit FDA UDI
Identifiers
- Catalog Number
- ACCK4310 FDA UDI
- Primary DI / UDI-DI
- 00813426020671 FDA UDI
- PMA Number
- P130022 FDA UDI
- FDA Product Code
- LGW FDA UDI
- GMDN Term
- Personal device holder, single-use FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Personal device holder, single-use
Senza by Nevro Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P130022 also covers:
- Nevro — Nevro Corporation
- Nevro — Nevro Corporation
- Nevro — Nevro Corporation
- Nevro® — Nevro Corporation
- Nevro® — Nevro Corporation
- Nevro® — Nevro Corporation
- Nevro® — Nevro Corporation
- Nevro® — Nevro Corporation
- Nevro® — Nevro Corporation
- Nevro® — Nevro Corporation
- Nevro® — Nevro Corporation
- Nevro® — Nevro Corporation
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
- Nevro Corporation
Sources (1)
- FDA UDI b0ebf704-bef5-4412-9654-c7f9c202758e 36 fields · synced May 30, 2026