Venclose System Foot Pedal

GUDID 00858254006039

Foot Pedal

VENCLOSE INC

Foot-switch, electrical
Primary Device ID00858254006039
NIH Device Record Key107c8486-08ad-46d7-bfbf-fedf1ab99305
Commercial Distribution StatusIn Commercial Distribution
Brand NameVenclose System Foot Pedal
Version Model NumberVC-FP-1
Company DUNS085838983
Company NameVENCLOSE 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100858254006039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-01

Devices Manufactured by VENCLOSE INC

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40858254006365 - EVSRF Procedure Pack2020-11-06 Venclose procedure pack - convenient kit.
00858254006039 - Venclose System Foot Pedal2018-07-06Foot Pedal
00858254006039 - Venclose System Foot Pedal2018-07-06 Foot Pedal
00858254006008 - Venclose System EVSRF Catheter2018-07-06 Endovenous Radiofrequency Ablation (RFA) Catheter, 60cm
00858254006015 - Venclose System EVSRF Catheter2018-07-06 Endovenous Radiofrequency Ablation (RFA) Catheter, 100cm
00858254006022 - Venclose System digiRF Generator2018-07-06 Radiofrequency Ablation (RFA) Generator
00858254006046 - Venclose System Power Cord2018-07-06 Power Cord, US
00858254006053 - Venclose System Power Cord2018-07-06 Power Cord, Germany, Finland, Netherlands, Spain, Turkey, France, Belgium, Czech Republic, Poland

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