FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00763000963040
·
Model: 64001
·
MEDTRONIC, INC.
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- N/A
- Primary DI
- 00763000963040
- Version / Model
- 64001
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-17
- Public Version
- 3
- Public Version Date
- 2026-04-13
- Public Version Status
- Update
- Public Device Record Key
- 58b1431d-e4ad-4b0f-9886-6773ff85d166
Device Description
ADAPTOR 64001 1X4 MVMT POCKET MDR US
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- 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 |
|---|---|---|---|---|
| NHL | Stimulator, electrical, implanted, for parkinsonian symptoms | Unknown | 3 | |
| PJS | Stimulator, electrical, implanted, for essential tremor | Unknown | 3 | |
| MHY | Stimulator, electrical, implanted, for parkinsonian tremor | Unknown | 3 | |
| MRU | implanted subcortical electrical Stimulator (motor disorders) | Unknown | f | |
| OLM | Deep brain stimulator for obsessive compulsive disorder (OCD) | Unknown | f | |
| SGS | Deep Brain Stimulation for the treatment of Dystonia | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48054 | Neural-tissue electrical stimulation lead adaptor | An implantable device intended to provide a functional and modified connection between existing neurostimulation leads/lead extensions and an implanted replacement neurostimulator [e.g., a spinal cord stimulation (SCS) or a deep brain stimulation (DBS) stimulator]. It typically consists of a small connector block to enable attachment to the existing stimulation leads (i.e., when they do not meet connection design) and connection to the replacement neurostimulator. During implantation, the surgeon uses a tool to tighten the connections (e.g., a Hex wrench) and a medical adhesive to seal the connections from body fluid contamination. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000963040 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P960009 | 486 |