Identity
- Trade Name
- MediMax Tech FDA UDI
- Generic Name
- Electrosurgical return electrode, single-use FDA UDI
- Device Name
- NMX42P Split Vertical Corded Foam Grounding Plate- Neo-Natal Use -Single Pack FDA UDI
- Model / Reference
- NMX42P ESU Plate FDA UDI
- Description
- NMX42P Split Vertical Corded Foam Grounding Plate- Neo-Natal Use -Single Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817325022897 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
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrosurgical return electrode, single-use
MediMax Tech by Medimax Tech Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K073360 also covers:
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- 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.
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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
- Medimax Tech Inc.
Sources (1)
- FDA UDI fa1ddd74-b7eb-4f5e-a2c9-82f2544e9768 35 fields · synced May 30, 2026