FDA UDI
In Commercial Distribution
🇺🇸 United States
EasyPrep Sensor Kit
DI: B746EK9011
·
Model: EK-901
·
Neurowave Systems Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- EasyPrep Sensor Kit
- Primary DI
- B746EK9011
- Version / Model
- EK-901
- Catalog Number
- EK-901
- Company Name
- Neurowave Systems Inc.
- Labeler DUNS
- 607075160
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2023-11-02
- Public Version
- 1
- Public Version Date
- 2023-11-10
- Public Version Status
- New
- Public Device Record Key
- 11b7cd2c-3625-42d3-81f8-4bb7d0f50ee2
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
- Yes
- MRI Safety
- MR Unsafe
- 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
- 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 |
|---|---|---|---|---|
| 11440 | Analytical scalp electrode, single-use | A noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B746EK9011 | HIBCC | ||||
| Unit of Use | B746EK9010 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202621 | 000 |