Venclose™ EVSRF™ Catheter

GUDID 00858254006183

Endovenous Radiofrequency Ablation (RFA) Catheter, 60cm, 10 pack

VENCLOSE INC

Radio-frequency ablation system
Primary Device ID00858254006183
NIH Device Record Key5385a7fb-9f95-40b8-81f6-1dff66f34274
Commercial Distribution StatusIn Commercial Distribution
Brand NameVenclose™ EVSRF™ Catheter
Version Model NumberVC-10A2.5-6F-60 [10X]
Company DUNS085838983
Company NameVENCLOSE INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
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 Dimensions

Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter
Length60 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100858254006183 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-11-01

On-Brand Devices [Venclose™ EVSRF™ Catheter]

00858254006190Endovenous Radiofrequency Ablation (RFA) Catheter, 100cm, 10 pack
00858254006183Endovenous Radiofrequency Ablation (RFA) Catheter, 60cm, 10 pack
00858254006176Endovenous Radiofrequency Ablation (RFA) Catheter, 100cm, 5 pack
00858254006169Endovenous Radiofrequency Ablation (RFA) Catheter, 60cm, 5 pack

Trademark Results [Venclose]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VENCLOSE
VENCLOSE
87777079 5584380 Live/Registered
Venclose, Inc.
2018-01-30

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