FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ATLAS Stim Headbox Software
DI: 00850011306703
·
Model: 1.5.1
·
NEURALYNX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ATLAS Stim Headbox Software
- Primary DI
- 00850011306703
- Version / Model
- 1.5.1
- Catalog Number
- 36-0301-0006
- Company Name
- NEURALYNX, INC.
- Labeler DUNS
- 933200842
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-11
- Public Version
- 1
- Public Version Date
- 2025-06-19
- Public Version Status
- New
- Public Device Record Key
- 57568104-9f7d-4de8-ba14-79017085b5fe
- Distribution End Date
- 2025-06-11
Device Description
Control software for the ATLAS Stim Headbox.
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 |
|---|---|---|---|---|
| GYC | Electrode, Cortical | Neurology | 882.1310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35726 | Somatosensory electrical stimulation system | An assembly of devices used to apply precisely timed and repeatable electrical stimuli to the peripheral nerves, typically for evoked potential and other research procedures (e.g., functional mapping in epilepsy). It is usually a multichannel external stimulation system, consisting of external surface electrodes or invasive (i.e., needle) electrodes, and a pulse generator. It may be used as a component of more complex devices such as somatosensory evoked-potential recording systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850011306703 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250094 | 000 |