FDA UDI
In Commercial Distribution
🇺🇸 United States
RNS® Neurostimulator Kit
DI: 00855547005267
·
Model: RNS-320-K
·
Neuropace, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RNS® Neurostimulator Kit
- Primary DI
- 00855547005267
- Version / Model
- RNS-320-K
- Company Name
- Neuropace, Inc.
- Labeler DUNS
- 123369238
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-18
- Public Version
- 6
- Public Version Date
- 2020-08-26
- Public Version Status
- Update
- Public Device Record Key
- c97befd4-cd4a-4459-a121-e2e2a01b27fc
Device Description
The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cover, 1 Ferrule, 1 Ferrule Clamp, 1 Lead Strain Relief and 1 Torque Driver.
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 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PFN | Implanted brain stimulator for epilepsy | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61947 | Brain-responsive electrical stimulation system | An assembly of devices designed to continuously monitor brain activity and deliver electrical stimuli to seizure foci in response to the detection of abnormal electrical events in the brain for the treatment of neurological disorders (e.g., epilepsy). It consists of a sterile, battery-powered sensing device/stimulator implanted below the scalp; one or more leads, which may be placed on the cortical surface or deep in the brain, and which transmit monitoring data, electrocorticograms and stimulation pulses; telemetric control units for programming the stimulator and/or receiving functional data; and software run on a computing device for analysis and reporting. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855547005267 | GS1 |
Customer Contacts
- Phone
- +1(866)726-3876
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P100026 | 000 |
| P100026 | 047 |
| P100026 | 050 |
| P100026 | 069 |
| P100026 | 075 |
| P100026 | 082 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 60 Degrees Celsius