Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R) VEN-PV-014R

GUDID 00860036000517

Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R)

Vein360 LLC

Intravascular ultrasound imaging catheter, reprocessed
Primary Device ID00860036000517
NIH Device Record Key043a0894-d2d8-4ca6-90c6-0d47bf84d44e
Commercial Distribution StatusIn Commercial Distribution
Brand NameVein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R)
Version Model NumberVEN-PV-014R
Catalog NumberVEN-PV-014R
Company DUNS080926907
Company NameVein360 LLC
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860036000517 [Primary]

FDA Product Code

OWQReprocessed Intravascular Ultrasound Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-02
Device Publish Date2024-03-25

Devices Manufactured by Vein360 LLC

00860036000517 - Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R)2024-04-02Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R)
00860036000517 - Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R)2024-04-02 Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R)
00860036000579 - Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P)2024-04-02 Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P)
00860036000586 - Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter2024-04-02 Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter
00860036000593 - Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter2024-04-02 Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter
00860036000524 - Reprocessed Visions PV.018 Digital IVUS Catheter2023-10-09 Reprocessed Visions PV.018 Digital IVUS Catheter
00860036000531 - Reprocessed Visions PV.035 Digital IVUS Catheter2023-09-06 Reprocessed Visions PV.035 Digital IVUS Catheter
10860036000545 - Endovenous Radiofrequency Ablation (RFA) Catheter2021-11-03 Endovenous Radiofrequency Ablation (RFA) Catheter 7-60
10860036000552 - Endovenous Radiofrequency Ablation (RFA) Catheter2021-11-03 Endovenous Radiofrequency Ablation (RFA) Catheter 7-100

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