Identity
- Trade Name
- MediMax Tech FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- SB Push Button ESU Pencil - 2.5'' Stainless Blade, No Holster, ESU Pencil, 10'' Cable FDA UDI
- Model / Reference
- SB Push Button ESU Pencil FDA UDI
- Description
- SB Push Button ESU Pencil - 2.5'' Stainless Blade, No Holster, ESU Pencil, 10'' Cable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817325020855 FDA UDI
- 510(k) Number
- K092732 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, monopolar, reusable 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
Yes
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: Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
MediMax Tech by Medimax Tech Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, reusable.
- ELMED — ELMED INCORPORATED · Class II
- ELMED — ELMED INCORPORATED · Class II
- ELMED INCORPORATED — ELMED INCORPORATED · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Electrode — SOPRO-COMEG GmbH · Class II
- Sklar® — Sklar Corporation · Class II
- PILLING — TELEFLEX INCORPORATED · Class II
- ELMED INCORPORATED — ELMED INCORPORATED · Class II
Cleared under the same submission
K092732 also covers:
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Dynamic DIAGNOSTICS, INC — BIOPROTECH INC.
- Dynamic DIAGNOSTICS, INC — BIOPROTECH INC.
- Dynamic DIAGNOSTICS, INC — BIOPROTECH INC.
- Dynamic DIAGNOSTICS, INC — BIOPROTECH INC.
- Dynamic DIAGNOSTICS, INC — BIOPROTECH INC.
- ERBE — BIOPROTECH INC.
- ERBE — BIOPROTECH INC.
- ERBE — BIOPROTECH INC.
- ERBE — BIOPROTECH INC.
- ERBE — BIOPROTECH 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
- Medimax Tech Inc.
Sources (1)
- FDA UDI 0abb3bc7-516f-4b6f-966d-d9836660b119 35 fields · synced Jun 8, 2026