FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00643169936607
·
Model: 64002
·
MEDTRONIC, INC.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 00643169936607
- Version / Model
- 64002
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 796986144
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-10
- Public Version
- 1
- Public Version Date
- 2018-09-10
- Public Version Status
- New
- Public Device Record Key
- ac685e47-a980-4733-a709-b01ec45afe35
Device Description
ADAPTOR 64002 2X4 MVMT POCKET ADAPTOR
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
- 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 |
|---|---|---|---|---|
| MRU | implanted subcortical electrical Stimulator (motor disorders) | Unknown | f | |
| NHL | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | Unknown | 3 | |
| OLM | Deep brain stimulator for obsessive compulsive disorder (OCD) | Unknown | f | |
| MHY | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48054 | Neural-tissue electrical stimulation lead adaptor | A sterile implantable device intended to provide a functional and modified connection between existing neurostimulation leads 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 | 00643169936607 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H020007 | 196 |
| H050003 | 165 |
| P960009 | 293 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -34 – 57 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 135 Degrees Fahrenheit