Identity
- Trade Name
- DBS™ FDA UDI
- Generic Name
- Deep brain electrical stimulation system FDA UDI
- Device Name
- LEAD KIT 3389S-40 DBS STMLOC ACTIVA EMAN FDA UDI
- Model / Reference
- 3389S-40 FDA UDI
- Description
- LEAD KIT 3389S-40 DBS STMLOC ACTIVA EMAN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000274405 FDA UDI
- FDA Product Code
- MRU FDA UDINHL FDA UDIPJS FDA UDIMBX FDA UDIMHY FDA UDI
- GMDN Term
- Deep brain electrical stimulation system FDA UDI
Classification
- Device Class
- Unclassified FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 40.0 Centimeter FDA UDI
Category: Deep brain electrical stimulation system
Dbs™ by Medtronic, Inc. — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Deep brain electrical stimulation system.
- Vercise™ — Boston Scientific Neuromodulation · Class III
- Vercise™ Cartesia™ — Boston Scientific Neuromodulation · Class III
- Vercise™ — Boston Scientific Neuromodulation · Class III
- Vercise™ DBS — Boston Scientific Neuromodulation · Class III
- Vercise™ Cartesia™ HX — Boston Scientific Neuromodulation · Class III
- Infinity™ — ST. JUDE MEDICAL, INC. · Class III
- Precision Spectra ™ — Boston Scientific Neuromodulation · Class III
- Vercise Genus™ — Boston Scientific Neuromodulation · Class III
Cleared under the same submission
H020007 also covers:
- Activa® PC — MEDTRONIC, INC.
- Activa® PC — MEDTRONIC, INC.
- Activa® SC — MEDTRONIC, INC.
- Activa® SC — MEDTRONIC, INC.
- MEDTRONIC® DBS™ — MEDTRONIC, INC.
- MEDTRONIC® DBS™ — MEDTRONIC, INC.
- MEDTRONIC® DBS™ — MEDTRONIC, INC.
- MEDTRONIC® DBS™ — MEDTRONIC, INC.
- MEDTRONIC® DBS™ — MEDTRONIC, INC.
- MEDTRONIC® DBS™ — MEDTRONIC, INC.
- MEDTRONIC® DBS™ — MEDTRONIC, INC.
- MEDTRONIC® DBS™ — MEDTRONIC, INC.
P960009 also covers:
- Activa® PC — MEDTRONIC, INC.
- Activa® RC — MEDTRONIC, INC.
- Activa® RC — MEDTRONIC, INC.
- Assess ® — MEDTRONIC, INC.
- DBS™ — MEDTRONIC, INC.
- Intercept ™ — MEDTRONIC, INC.
- N'VISION 8840 — MEDTRONIC, INC.
- Percept™ PC BrainSense™ — MEDTRONIC, INC.
- SenSight™ — MEDTRONIC, INC.
- SenSight™ — MEDTRONIC, INC.
- SenSight™ — MEDTRONIC, INC.
- SenSight™ — MEDTRONIC, INC.
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 Unclassified | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 50f5d3b7-3619-42a8-947f-13760136aea5 37 fields · synced May 30, 2026