Identity
- Trade Name
- EndyGel FDA UDI
- Generic Name
- Skin topical coupling gel FDA UDI
- Device Name
- EndyGel is an Electroconductive gel media used with external electrode to reduce the impedance (resistance to alternating current) of the contract between the electrode surface and the skin. FDA UDI
- Model / Reference
- EndyGel 350 ml FDA UDI
- Description
- EndyGel is an Electroconductive gel media used with external electrode to reduce the impedance (resistance to alternating current) of the contract between the electrode surface and the skin. FDA UDI
Identifiers
- Catalog Number
- ND_PRD00016 FDA UDI
- Primary DI / UDI-DI
- 07290016814354 FDA UDI
- 510(k) Number
- K161715 FDA UDI
- FDA Product Code
- GYB FDA UDI
- GMDN Term
- Skin topical coupling gel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1275 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin topical coupling gel
EndyGel by Endymed Medical Ltd — 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
- Endymed Medical Ltd
Sources (1)
- FDA UDI c22f1e4d-e900-4560-a39d-10e9ec8881ac 37 fields · synced Jun 8, 2026