Identity
- Trade Name
- ATLAS-HS-36-CHET-TETHER FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- The ATLAS-CHET-36-TETHER is a connection between the ATLAS-HS-36-CHET-X headstage and the ATLAS Neurophysiology System; Note X denotes the type of electrode connection for the CHET, while the TETHER is compatible with multiple CHET-X designs. FDA UDI
- Model / Reference
- ATLAS-HS-36-CHET-TETHER FDA UDI
- Description
- The ATLAS-CHET-36-TETHER is a connection between the ATLAS-HS-36-CHET-X headstage and the ATLAS Neurophysiology System; Note X denotes the type of electrode connection for the CHET, while the TETHER is compatible with multiple CHET-X designs. FDA UDI
Identifiers
- Catalog Number
- 31-0613-0026 FDA UDI
- Primary DI / UDI-DI
- 00850011306000 FDA UDI
- FDA Product Code
- IKD FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1175 FDA UDI
- Commercial Distribution
- 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
Category: Electrical-only medical device connection cable, reusable
Atlas-Hs-36-Chet-Tether by Neuralynx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Neuralynx, Inc.
Sources (1)
- FDA UDI 00a1427e-f125-4bec-bf2b-46707f557a0e 35 fields · synced Jun 6, 2026