Identity
- Trade Name
- Gentle Patch FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Electrodes 2.0"x2.0" Blue Gel Adhesive For Sensitive Skin (1 Pack = 4 Electrodes Per Pack) FDA UDI
- Model / Reference
- ProM-027 FDA UDI
- Description
- Electrodes 2.0"x2.0" Blue Gel Adhesive For Sensitive Skin (1 Pack = 4 Electrodes Per Pack) FDA UDI
Identifiers
- Catalog Number
- ProM-027 FDA UDI
- Primary DI / UDI-DI
- 00185098000818 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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: Transcutaneous electrical stimulation electrode, single-use
Gentle Patch by Pro Medical Supplies, 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
- Pro Medical Supplies, Inc.
Sources (1)
- FDA UDI a33a29e4-623d-4d2f-b567-ab51bad65ef9 35 fields · synced May 30, 2026