Disposable Monopolar Handswitching Pencil

GUDID 00815871020091

Avante

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Primary Device ID00815871020091
NIH Device Record Keye4cd08a1-0a54-4503-8f40-329d4f43fc49
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Monopolar Handswitching Pencil
Version Model NumberP00507
Company DUNS178440426
Company NameAvante
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100815871020091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-02
Device Publish Date2016-09-23

Devices Manufactured by Avante

00815871020091 - Disposable Monopolar Handswitching Pencil2020-03-02
00815871020091 - Disposable Monopolar Handswitching Pencil2020-03-02
00815871020190 - Compact FM2020-03-02
00815871020206 - Compact FM2020-03-02
00815871020213 - Compact FM2020-03-02
00815871020220 - Compact FM2020-03-02
00815871020237 - Compact Plus2020-03-02
00815871020244 - Compact Plus2020-03-02
00815871020251 - Compact Plus2020-03-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.