Identity
- Trade Name
- DBS™ FDA UDI
- Generic Name
- Deep brain electrical stimulation system FDA UDI
- Device Name
- LEAD KIT 3391S-40 DBS STMLC RECLAIM EMAN FDA UDI
- Model / Reference
- 3391S-40 FDA UDI
- Description
- LEAD KIT 3391S-40 DBS STMLC RECLAIM EMAN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000274412 FDA UDI
- PMA Number
- H050003 FDA UDI
- FDA Product Code
- OLM 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.
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- 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
H050003 also covers:
- Access® Therapy Controller — MEDTRONIC, INC.
- Activa® PC — MEDTRONIC, INC.
- Activa® PC — MEDTRONIC, INC.
- Activa® SC — MEDTRONIC, INC.
- Activa® SC — MEDTRONIC, INC.
- Activa® SC — MEDTRONIC, INC.
- Assess ® — MEDTRONIC, INC.
- DBS™ Reclaim® — MEDTRONIC, INC.
- N'VISION ® — MEDTRONIC, INC.
- N'VISION™ — MEDTRONIC, INC.
- Percept™ PC BrainSense™ — 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 |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 38f1ab88-29d6-4297-96b8-f14d00a5eab8 37 fields · synced May 30, 2026