REUSABLE ELECTROSURGERY 3-BUTTON PENCIL A901

GUDID 00192896009288

REUSABLE ELECTROSURGERY 3-BUTTON PENCIL

SONTEC INSTRUMENTS, INC.

Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Primary Device ID00192896009288
NIH Device Record Keycc92dbfe-4685-49db-a077-60ecc3a9cf4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameREUSABLE ELECTROSURGERY 3-BUTTON PENCIL
Version Model NumberA901
Catalog NumberA901
Company DUNS040729840
Company NameSONTEC INSTRUMENTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896009288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896009288]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896009288]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896009288]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-17
Device Publish Date2018-08-15

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