Vascular Dilator Kit

GUDID 00803622112522

LIVANOVA USA, INC.

Vascular catheter introduction set, nonimplantable
Primary Device ID00803622112522
NIH Device Record Keyd5eb2527-5dfb-4b74-98bc-f043d6dcb146
Commercial Distribution StatusIn Commercial Distribution
Brand NameVascular Dilator Kit
Version Model Number200-120
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
GS100803622112522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-06-07
Device Publish Date2014-12-22

On-Brand Devices [Vascular Dilator Kit]

00803622112522200-120
00803622146947200-120

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