Identity
- Trade Name
- SureTune™ 4 FDA UDI
- Generic Name
- Implantable electrical stimulation device management software FDA UDI
- Device Name
- SW B36104A SURETUNE4 DBS STANDALONE FDA UDI
- Model / Reference
- B36104A FDA UDI
- Description
- SW B36104A SURETUNE4 DBS STANDALONE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000496432 FDA UDI
- 510(k) Number
- DEN210003 FDA UDI
- FDA Product Code
- QQC FDA UDI
- GMDN Term
- Implantable electrical stimulation device management software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5855 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
No
FDA UDI
Category: Implantable electrical stimulation device management software
SureTune™ 4 by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
DEN210003 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 7425e636-9f16-43a7-bfe9-afe381e79954 35 fields · synced Jun 8, 2026