Identity
- Trade Name
- Nalu Medical, Inc. FDA UDI
- Generic Name
- Implantable electrical stimulation device management software FDA UDI
- Device Name
- SCS Remote App (compatible with iOS) FDA UDI
- Model / Reference
- 53002-002 FDA UDI
- Description
- SCS Remote App (compatible with iOS) FDA UDI
Identifiers
- Catalog Number
- 53002-002 FDA UDI
- Primary DI / UDI-DI
- 00812537033013 FDA UDI
- FDA Product Code
- GZF FDA UDIGZB FDA UDI
- GMDN Term
- Implantable electrical stimulation device management software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5870 FDA UDI882.5880 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Implantable electrical stimulation device management software
Nalu Medical, Inc. by Nalu Medical — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Nalu Medical
Sources (1)
- FDA UDI 9f2e9213-8c9b-4427-a5d9-81e77b0eb2d9 35 fields · synced May 30, 2026