VSI Micro-HV Introducer Kit CLI-810-28

GUDID 20841268106745

VSI Micro-HV Introducer Kit

GALT MEDICAL CORP.

Haemostasis valve
Primary Device ID20841268106745
NIH Device Record Key84ffeda2-cb3b-4fca-991d-d8d61a8ac74e
Commercial Distribution StatusIn Commercial Distribution
Brand NameVSI Micro-HV Introducer Kit
Version Model NumberCLI-810-28
Catalog NumberCLI-810-28
Company DUNS943156836
Company NameGALT MEDICAL CORP.
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 Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-639-2800
Emailcustomerservice@galtneedletech.com

Device Dimensions

Catheter Gauge7 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100841268106741 [Primary]
GS110841268106748 [Package]
Contains: 00841268106741
Package: Shelf Box [5 Units]
In Commercial Distribution
GS120841268106745 [Package]
Contains: 10841268106748
Package: Shipper Box [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20841268106745]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-05
Device Publish Date2019-05-28

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