Identity
- Trade Name
- MediMax Tech FDA UDI
- Generic Name
- Electrosurgical return electrode, single-use FDA UDI
- Device Name
- MXP51F ESU Plate: Corded, Foam, Single, Grounding Pad. FDA UDI
- Model / Reference
- MXP51F ESU Plate FDA UDI
- Description
- MXP51F ESU Plate: Corded, Foam, Single, Grounding Pad. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817325021111 FDA UDI
- 510(k) Number
- K073360 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical return electrode, single-use 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Electrosurgical return electrode, single-use
MediMax Tech's Electrosurgical Return Electrode (MXP51F ESU Plate) is a fastening device specifically designed to be used with electrosurgical/radio-frequency ablation systems. This electrode provides optimal placement and electrical conductivity, ensuring reliable return of current to the generator during procedures. With its large surface area and permanent attachment to the patient's body, it can effectively cover areas closest to the surgical site.
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Cleared under the same submission
K073360 also covers:
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Dynamic DIAGNOSTICS, INC — BIOPROTECH INC.
- Dynamic DIAGNOSTICS, INC — BIOPROTECH INC.
- PROPLATE — BIOPROTECH INC.
- PROPLATE — BIOPROTECH INC.
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Medimax Tech Inc.
Sources (1)
- FDA UDI de3c0d33-a368-4ecf-a19b-f5d3a2e28064 35 fields · synced Jul 17, 2026