Identity
- Trade Name
- Patient Dispercive Pad FDA UDI
- Generic Name
- Electrosurgical return electrode, single-use, sterile FDA UDI
- Model / Reference
- 21-809 FDA UDI
Identifiers
- Primary DI / UDI-DI
- GYNX218091 FDA UDI
- 510(k) Number
- K091672 FDA UDI
- FDA Product Code
- ODR FDA UDI
- GMDN Term
- Electrosurgical return electrode, single-use, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrosurgical return electrode, single-use, sterile
Patient Dispercive Pad by Gynex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrosurgical return electrode, single-use, sterile.
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- Disposable Grounding Pad Series — Zhejiang Shuyou Surgical Instrument Co., Ltd. · Class II
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- L’DISQ® — CG MedTech Co., Ltd. · Class II
- Disposable Grounding Pad Series — Zhejiang Shuyou Surgical Instrument Co., Ltd. · Class II
- Neutral Plate — Soniquence, LLC · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
Cleared under the same submission
K091672 also covers:
- Patient Dispersive Pad — GYNEX CORPORATION
- Patient Dispersive Pad — GYNEX CORPORATION
- Hayden Medical — Hayden Medical Inc
- Hayden Medical — Hayden Medical Inc
- Hayden Medical — Hayden Medical Inc
- Hayden Medical — Hayden Medical Inc
- Hayden Medical — Hayden Medical Inc
- Hayden Medical — Hayden Medical Inc
- Hayden Medical — Hayden Medical Inc
- Hayden Medical — Hayden Medical Inc
- Hayden Medical — Hayden Medical Inc
- Hayden Medical — Hayden Medical 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
- Gynex Corporation
Sources (1)
- FDA UDI 387a9ad1-fc17-4f27-a0d6-da09c08930bb 33 fields · synced Jun 6, 2026