X-Surge

GUDID 00877972006695

GENICON, INC.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Primary Device ID00877972006695
NIH Device Record Key76191c06-59ef-467c-a495-285d49171492
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-Surge
Version Model Number590-005-010
Company DUNS079805400
Company NameGENICON, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100877972006695 [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 Number4
Public Version Date2019-02-21
Device Publish Date2017-11-02

On-Brand Devices [X-Surge]

00877972007210590-005-005
00877972006732590-005-001
00877972006725590-005-014
00877972006695590-005-010
00877972006718590-005-013

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