Identity
- Trade Name
- XactTrode Patient Cable FDA UDI
- Generic Name
- Electroencephalographic signal amplifier FDA UDI
- Device Name
- XactTrode Patient Cable, 48 Contact with DIN Lead Connector, 6ft FDA UDI
- Model / Reference
- 028904 FDA UDI
- Description
- XactTrode Patient Cable, 48 Contact with DIN Lead Connector, 6ft FDA UDI
Identifiers
- Catalog Number
- 028904 FDA UDI
- Primary DI / UDI-DI
- 00814901021121 FDA UDI
- 510(k) Number
- K191346 FDA UDI
- FDA Product Code
- IKD FDA UDI
- GMDN Term
- Electroencephalographic signal amplifier 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 6 Feet FDA UDI
Category: Electroencephalographic signal amplifier
XactTrode Patient Cable by Blackrock Microsystems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electroencephalographic signal amplifier.
- eego amplifier — eemagine Medical Imaging Solutions GmbH · Class II
- ATLAS MICROMED JB INTERFACE — NEURALYNX, INC. · Class II
- Component Neuromonitoring System — Moberg Research, Inc. · Class II
- ATLAS-HS-36-CHET-A9 — NEURALYNX, INC. · Class II
- Global Reference Module 1 — NEURALYNX, INC. · Class II
- NATUS NEUROLOGY — Natus Neurology Incorporated · Class II
- ATLAS Cart — NEURALYNX, INC. · Class II
- ATLAS Ground Drive — NEURALYNX, INC. · Class II
Cleared under the same submission
K191346 also covers:
- XactGrid — Blackrock Microsystems
- XactGrid — Blackrock Microsystems
- XactGrid — Blackrock Microsystems
- XactGrid — Blackrock Microsystems
- XactGrid — Blackrock Microsystems
- XactGrid — Blackrock Microsystems
- XactGrid — Blackrock Microsystems
- XactGrid — Blackrock Microsystems
- XactGrid — Blackrock Microsystems
- XactGrid — Blackrock Microsystems
- XactGrid — Blackrock Microsystems
- XactGrid — Blackrock Microsystems
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
- Blackrock Microsystems
Sources (1)
- FDA UDI 4baf3265-86e6-4bcf-9682-cf0e47f8487a 37 fields · synced May 30, 2026