FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 05415067045713
·
Model: 12710
·
ADVANCED NEUROMODULATION SYSTEMS, INC.
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 05415067045713
- Version / Model
- 12710
- Catalog Number
- 12710
- Company Name
- ADVANCED NEUROMODULATION SYSTEMS, INC.
- Labeler DUNS
- 021675699
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-04
- Public Version
- 2
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- 1d5d08dd-bf6f-4a2a-a7f8-fa91e9e1f0a0
Device Description
Port Plug
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PJS | Stimulator, electrical, implanted, for essential tremor | Unknown | 3 | |
| NHL | Stimulator, electrical, implanted, for parkinsonian symptoms | Unknown | 3 | |
| MHY | Stimulator, electrical, implanted, for parkinsonian tremor | Unknown | 3 | |
| LGW | Stimulator, spinal-cord, totally implanted for pain relief | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44900 | Implantable pulse generator port plug | A non-active implantable device designed for insertion into the vacant/unused connector port of an implantable pulse generator (e.g., cardiac pacemaker/defibrillator, neurostimulator) to seal and electrically isolate the port, and to protect the parent device. It is typically made of metal and/or polymer materials. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05415067045713 | GS1 | ||||
| Package | 15415067045710 | GS1 | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P010032 | 186 |
| P140009 | 087 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- Low: 73 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- Low: 23 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73°F)