Venos Occlusion Balloon Catheter V058015

GUDID 00836559007074

Occlusion Balloon Catheter, 5F

Oscor Inc.

Cardiac sizing catheter
Primary Device ID00836559007074
NIH Device Record Keyc2b890d1-360c-4989-b713-aaeacce58587
Commercial Distribution Discontinuation2017-10-27
Commercial Distribution StatusNot in Commercial Distribution
Brand NameVenos Occlusion Balloon Catheter
Version Model NumberV058015
Catalog NumberV058015
Company DUNS101835833
Company NameOscor 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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(727)937-2511
Emailsales@oscor.com

Device Dimensions

Length80 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100836559007074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYGCATHETER, FLOW DIRECTED

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00836559007074]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-30

On-Brand Devices [Venos Occlusion Balloon Catheter]

00836559007111Occlusion Balloon Catheter, 6F
00836559007104Occlusion Balloon Catheter, 6F
00836559007098Occlusion Balloon Catheter, 6F
00836559007081Occlusion Balloon Catheter, 5F
00836559007074Occlusion Balloon Catheter, 5F
00836559006930Occlusion Balloon Catheter, 6F
00836559006923Occlusion Balloon Catheter, 6F
00836559006916Occlusion Balloon Catheter, 5F
00836559006909Occlusion Balloon Catheter, 5F

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