FDA UDI
In Commercial Distribution
🇺🇸 United States
Neuronaute IceCap
DI: 03615220001521
·
Model: 1001-01010-US
·
BIOSERENITY MEDICAL DEVICES GROUP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Neuronaute IceCap
- Primary DI
- 03615220001521
- Version / Model
- 1001-01010-US
- Company Name
- BIOSERENITY MEDICAL DEVICES GROUP
- Labeler DUNS
- 281224773
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-15
- Public Version
- 3
- Public Version Date
- 2023-12-28
- Public Version Status
- Update
- Public Device Record Key
- 66f43a0f-62af-4ebe-9dc2-b461e7b938e8
Device Description
The Neuronaute IceCap is intended to acquire, display, store, and archive EEG signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations in order to assist in the diagnosis of neurological disorders by a physician.
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
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17554 | Electroencephalographic electrode cap, single-use | An array of analytical scalp electrodes preconfigured within a head-worn device designed for the rapid placement and appropriate positioning of the scalp electrodes during electroencephalography (EEG). It typically consists of a cap-like device with integrated scalp electrodes, and shielded lead wires that terminate into a connector that mates with a separate cable. The device eliminates the need to glue or paste individual electrodes to the patient’s scalp. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03615220001521 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202334 | 000 |