Identity
- Trade Name
- The Electrode Store FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- Protectrode Disposable Mono. Needle Electrode, NO CABLE, 37mm(1.5")X27 ga FDA UDI
- Model / Reference
- DMD-37(PKG/30) FDA UDI
- Description
- Protectrode Disposable Mono. Needle Electrode, NO CABLE, 37mm(1.5")X27 ga FDA UDI
Identifiers
- Catalog Number
- DMD-37(PKG/30) FDA UDI
- Primary DI / UDI-DI
- 00816022020083 FDA UDI
- 510(k) Number
- K926094 FDA UDI
- FDA Product Code
- GXZ FDA UDI
- GMDN Term
- Electromyographic needle electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electromyographic needle electrode, single-use
The Electrode Store by Impulse Medical Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K926094 also covers:
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, 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
- Impulse Medical Technologies, Inc.
Sources (1)
- FDA UDI b52c672c-4df8-47f8-be01-4ace7f94430f 35 fields · synced May 30, 2026