FDA UDI
In Commercial Distribution
🇺🇸 United States
ATLAS Patient Event Marker
DI: 00850011306192
·
Model: ATLAS Patient Event Marker
·
NEURALYNX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ATLAS Patient Event Marker
- Primary DI
- 00850011306192
- Version / Model
- ATLAS Patient Event Marker
- Catalog Number
- 31-0604-0133
- 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
- 2
- Public Version Date
- 2023-10-17
- Public Version Status
- Update
- Public Device Record Key
- 93ed18ea-1597-40fe-b5b0-2c9b749e7ac8
Device Description
The ATLAS Patient Event Marker is an optional configuration of the ATLAS Neurophysiology System that allows the patient to mark an event in the Data Acquisition Software.
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
- Yes
- 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 |
|---|---|---|---|---|
| IKD | Cable, Electrode | Physical Medicine | 890.1175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47487 | Electrical-only medical device connection cable, reusable | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850011306192 | GS1 |
Customer Contacts
- Phone
- 406-585-4542
- [email protected]