FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DBS ™
DI: 00643169313552
·
Model: 3391S-40
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DBS ™
- Primary DI
- 00643169313552
- Version / Model
- 3391S-40
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 796986144
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-23
- Public Version
- 4
- Public Version Date
- 2023-07-12
- Public Version Status
- Update
- Public Device Record Key
- 598fd628-d971-4067-b542-3321d6ac1af0
- Distribution End Date
- 2023-05-24
Device Description
LEAD 3391S-40 PSYCH DBS OCD HDE EMAN
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OLM | Deep brain stimulator for obsessive compulsive disorder (OCD) | Unknown | f |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37307 | Deep brain electrical stimulation system | An assembly of sterile implantable devices designed to apply electrical stimuli to specific areas of the deep brain for the treatment of movement disorders (e.g. essential tremor, symptoms of Parkinson’s disease, epilepsy, dystonia), psychiatric disorders (e.g. obsessive-compulsive disorder, depression, anxiety disorder), and/or to treat chronic, severe, intractable pain. It typically consists of leads implanted in the brain, lead extensions, and a pulse generator that is typically implanted near the sternum. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00643169313552 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H050003 | 060 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 40.0 | Centimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -34 – 57 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- -30 – 135 Degrees Fahrenheit