Identity
- Trade Name
- MEDTRONIC® DBS™ FDA UDI
- Generic Name
- Deep brain electrical stimulation system FDA UDI
- Device Name
- LIT 3317L DYSTONIA 37601 W/3387S DBS FDA UDI
- Model / Reference
- 3317L FDA UDI
- Description
- LIT 3317L DYSTONIA 37601 W/3387S DBS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000007584 FDA UDI
- PMA Number
- H020007 FDA UDI
- FDA Product Code
- MRU 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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: Deep brain electrical stimulation system
Medtronic® Dbs™ by Medtronic, Inc. — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Deep brain electrical stimulation system.
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Cleared under the same submission
H020007 also covers:
- Activa® PC — MEDTRONIC, INC.
- Activa® PC — MEDTRONIC, INC.
- Activa® SC — MEDTRONIC, INC.
- Activa® SC — MEDTRONIC, INC.
- 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.
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 8910a9e3-1110-4b7d-af0a-dc571c098b3a 35 fields · synced Jun 8, 2026