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Maxtown Medical

FDA UDI

Class II (US FDA UDI)

by Modern Surgical Instruments LLC

Identity

Trade Name
Maxtown Medical FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Device Name
Bipolar Insulated Shepard .6mm Tip Angled 4.6" FDA UDI
Model / Reference
3-611-00 FDA UDI
Description
Bipolar Insulated Shepard .6mm Tip Angled 4.6" FDA UDI

Identifiers

Primary DI / UDI-DI
B4193611000 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Open-surgery electrosurgical handpiece/electrode, bipolar, 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Maxtown Medical by Modern Surgical Instruments LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Modern Surgical Instruments LLC

Sources (1)

  • FDA UDI b3ca8f59-53f4-4ea8-9f52-fe52810fc265 33 fields · synced Jun 8, 2026