Identity
- Trade Name
- X-Series FDA UDI
- Generic Name
- Electrode conductive medium FDA UDI
- Device Name
- Synapse Cream Kit FDA UDI
- Model / Reference
- XS02-4351 FDA UDI
- Description
- Synapse Cream Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851113007451 FDA UDI
- 510(k) Number
- K131383 FDA UDI
- FDA Product Code
- OMC FDA UDIGWQ FDA UDI
- GMDN Term
- Electrode conductive medium FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrode conductive medium
X-Series by Advanced Brain Monitoring, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131383 also covers:
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
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
- Advanced Brain Monitoring, Inc.
Sources (1)
- FDA UDI fb603bbc-db2c-494c-90b2-bbbb4ea0103c 35 fields · synced Jun 8, 2026