Identity
- Trade Name
- ATLAS-HS-36-CHET-IDC10 FDA UDI
- Generic Name
- Electroencephalographic signal amplifier FDA UDI
- Device Name
- The ATLAS-HS-36-CHET-IDC10 is a clinical headstage that allows four X 3M 10 Pin Receptacle Connector (e.g. 8510-4500PL) connectors to interface with the ATLAS Data Acquisition System. The ATLAS-HS-36-CHET-IDC10 uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized. FDA UDI
- Model / Reference
- ATLAS-HS-36-CHET-IDC10 FDA UDI
- Description
- The ATLAS-HS-36-CHET-IDC10 is a clinical headstage that allows four X 3M 10 Pin Receptacle Connector (e.g. 8510-4500PL) connectors to interface with the ATLAS Data Acquisition System. The ATLAS-HS-36-CHET-IDC10 uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized. FDA UDI
Identifiers
- Catalog Number
- 31-0601-0087 FDA UDI
- Primary DI / UDI-DI
- 00850011306222 FDA UDI
- FDA Product Code
- GWL FDA UDI
- GMDN Term
- Electroencephalographic signal amplifier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1835 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Atlas-Hs-36-Chet-Idc10 by Neuralynx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neuralynx, Inc.
Sources (1)
- FDA UDI 17e500b7-8582-434b-a567-2bac2ddcbc8d 36 fields · synced May 31, 2026