FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 05415067051899
·
Model: 66700
·
ADVANCED NEUROMODULATION SYSTEMS, INC.
Product Codes
3
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 05415067051899
- Version / Model
- 66700
- Catalog Number
- 66700
- Company Name
- ADVANCED NEUROMODULATION SYSTEMS, INC.
- Labeler DUNS
- 021675699
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-24
- Public Version
- 2
- Public Version Date
- 2025-12-15
- Public Version Status
- Update
- Public Device Record Key
- b8b38911-42b3-4d7c-aa27-1471e4c1c0d9
Device Description
DBS Charging System
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NHL | Stimulator, electrical, implanted, for parkinsonian symptoms | Unknown | 3 | |
| MHY | Stimulator, electrical, implanted, for parkinsonian tremor | Unknown | 3 | |
| PJS | Stimulator, electrical, implanted, for essential tremor | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33658 | Implant battery charger | An electronic device intended to be used to wirelessly recharge the batteries of an active implantable device in situ. It is not intended to program or extract data from (read) the implanted device. Battery-powered device types may include a line-powered charger (e.g., docking station); devices intended to hold/stabilise the device during use (e.g., implant battery charger belt/collar) may be included with this device. | No | Active |
| 57996 | Active implantable device control magnet | A hand-operated, non-sterile, magnetic device designed to be used by a patient and a healthcare professional to switch an active implantable device (e.g., pulse generator, implantable cardiac monitor) on and off. It typically consists of a small portable magnet (e.g., strontium ferrite) coated with an epoxy that can be carried in the pocket or a handbag (purse) of a patient for convenient access. It is placed by the patient against the skin directly over the site of the implant and turned as prescribed by the manufacturer. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05415067051899 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P140009 | 106 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Excursions permitted from -10 - 55C. Store at room temperature 23C (73F)