Vein Irrigation

GUDID 10803622133104

LIVANOVA USA, INC.

Vascular dilator, reusable
Primary Device ID10803622133104
NIH Device Record Key2b323ee4-bff2-4843-a832-c73dd995b635
Commercial Distribution StatusIn Commercial Distribution
Brand NameVein Irrigation
Version Model NumberVIC
Company DUNS080914995
Company NameLIVANOVA USA, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100803622133107 [Primary]
GS110803622133104 [Package]
Contains: 00803622133107
Package: CASE [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWPDILATOR, VESSEL, SURGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-15
Device Publish Date2016-08-01

On-Brand Devices [Vein Irrigation]

10803622133104VIC
10803622133098BIC

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