FDA UDI
In Commercial Distribution
🇺🇸 United States
NeuroSphere™
DI: 05415067050311
·
Model: 3876
·
ADVANCED NEUROMODULATION SYSTEMS, INC.
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NeuroSphere™
- Primary DI
- 05415067050311
- Version / Model
- 3876
- Catalog Number
- 3876
- Company Name
- ADVANCED NEUROMODULATION SYSTEMS, INC.
- Labeler DUNS
- 021675699
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-17
- Public Version
- 1
- Public Version Date
- 2025-01-27
- Public Version Status
- New
- Public Device Record Key
- e76891fd-6f54-4a34-a152-1ea2d74ec860
Device Description
Digital Health App
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MHY | Stimulator, electrical, implanted, for parkinsonian tremor | Unknown | 3 | |
| PMP | Dorsal root ganglion stimulator for pain relief | Unknown | 3 | |
| LGW | Stimulator, spinal-cord, totally implanted for pain relief | Unknown | 3 | |
| NHL | Stimulator, electrical, implanted, for parkinsonian symptoms | Unknown | 3 | |
| PJS | Stimulator, electrical, implanted, for essential tremor | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61393 | Multiple active implantable device programmer | An external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05415067050311 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P010032 | 213 |
| P140009 | 095 |
| P150004 | 071 |