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Reusable Electrosurgery Push Button Pencil

FDA UDI

Class II (US FDA UDI)

by Sontec Instruments, Inc.

Identity

Trade Name
REUSABLE ELECTROSURGERY PUSH BUTTON PENCIL FDA UDI
Generic Name
Open-surgery electrosurgical electrode, monopolar, reusable FDA UDI
Device Name
REUSABLE ELECTROSURGERY PUSH BUTTON PENCIL FDA UDI
Model / Reference
ESPR2 FDA UDI
Description
REUSABLE ELECTROSURGERY PUSH BUTTON PENCIL FDA UDI

Identifiers

Catalog Number
ESPR2 FDA UDI
Primary DI / UDI-DI
00192896009431 FDA UDI
510(k) Number
K984352 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Open-surgery electrosurgical 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 3 Meter FDA UDI

Category: Open-surgery electrosurgical electrode, monopolar, reusable

Reusable Electrosurgery Push Button Pencil by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery electrosurgical electrode, monopolar, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sontec Instruments, Inc.

Sources (1)

  • FDA UDI 4233bfe0-21ca-4e66-8c13-db1bf7161467 37 fields · synced May 30, 2026