FDA UDI
In Commercial Distribution
🇺🇸 United States
ATLAS-HS-10-CHET-A 1.0
DI: 00850011306024
·
Model: 1.0
·
NEURALYNX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ATLAS-HS-10-CHET-A 1.0
- Primary DI
- 00850011306024
- Version / Model
- 1.0
- Catalog Number
- HS-10-CHET-A 1.0
- Company Name
- NEURALYNX, INC.
- Labeler DUNS
- 933200842
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-19
- Public Version
- 1
- Public Version Date
- 2022-09-27
- Public Version Status
- New
- Public Device Record Key
- 6b9355b6-ffa6-470c-982a-bab0ccfe20cd
Device Description
The HS-10-CHET-A 1.0 is a clinical headstage that allows one Ad-Tech Tail Electrode (usually consisting of up to 9 electrodes) to interface with the ATLAS Neurophysiology 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| OMC | Reduced- Montage Standard Electroencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35196 | Electroencephalographic monitoring system, stationary | A mains electricity (AC-powered) device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function. It may be capable of monitoring various other physiological parameters such as electromyogram (EMG), respiration wave forms, blood pressure, ocular motility, and/or haemoglobin oxygen saturation (SpO2) and carbon dioxide (CO2) in relation to EEG. It includes a control unit, electrodes, and components (e.g., amplifier, cables, probes); it is a stationary device and commonly used at the patient's bedside, in an intensive care unit (ICU), or in a dedicated EEG monitoring room. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850011306024 | GS1 |
Customer Contacts
- Phone
- 406-585-4542
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110967 | 000 |