Identity
- Trade Name
- Micromed FDA UDI
- Generic Name
- Somatosensory electrical stimulation system FDA UDI
- Device Name
- The SD LTM STIM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG). FDA UDI
- Model / Reference
- SD LTM STIM FDA UDI
- Description
- The SD LTM STIM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033928120828 FDA UDI
- 510(k) Number
- K180761 FDA UDI
- FDA Product Code
- GYC FDA UDI
- GMDN Term
- Somatosensory electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1310 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
Yes
FDA UDI
Category: Somatosensory electrical stimulation system
Micromed by Micromed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Somatosensory electrical stimulation system.
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- USB to Electrical Stimulation Box Cable — Intelligent Hearing Systems Corp. · Class II
- ATLAS Stim Headbox - Touchproof — NEURALYNX, INC. · Class II
- Electrical Stimulator Probe — Intelligent Hearing Systems Corp. · Class II
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
- Micromed, Inc.
Sources (1)
- FDA UDI e66b9144-97bc-433f-b1d8-df8cd84a53c3 34 fields · synced Jun 8, 2026