Elite HV® R Hydrophilic Introducer Kit CLI-229-45

GUDID 10841268109350

Elite HV® R Hydrophilic Introducer Kit

GALT MEDICAL CORP.

Haemostasis valve
Primary Device ID10841268109350
NIH Device Record Keyc060f33e-417f-4821-b95b-cdc2f1bef374
Commercial Distribution StatusIn Commercial Distribution
Brand NameElite HV® R Hydrophilic Introducer Kit
Version Model NumberCLI-229-45
Catalog NumberCLI-229-45
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
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com
Phone800-639-2800
Emailcustomerservice@galtneedletech.com

Device Dimensions

Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100841268109353 [Primary]
GS110841268109350 [Package]
Contains: 00841268109353
Package: Shelf Box [5 Units]
In Commercial Distribution
GS120841268109357 [Package]
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

[10841268109350]

Ethylene Oxide


[10841268109350]

Ethylene Oxide


[10841268109350]

Ethylene Oxide


[10841268109350]

Ethylene Oxide


[10841268109350]

Ethylene Oxide


[10841268109350]

Ethylene Oxide


[10841268109350]

Ethylene Oxide


[10841268109350]

Ethylene Oxide


[10841268109350]

Ethylene Oxide


[10841268109350]

Ethylene Oxide


[10841268109350]

Ethylene Oxide


[10841268109350]

Ethylene Oxide


[10841268109350]

Ethylene Oxide


[10841268109350]

Ethylene Oxide


[10841268109350]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-21
Device Publish Date2020-12-11

On-Brand Devices [Elite HV® R Hydrophilic Introducer Kit]

10841268109442Elite HV® R Hydrophilic Introducer Kit
10841268109435Elite HV® R Hydrophilic Introducer Kit
10841268109428Elite HV® R Hydrophilic Introducer Kit
10841268109411Elite HV® R Hydrophilic Introducer Kit
10841268109404Elite HV® R Hydrophilic Introducer Kit
10841268109398Elite HV® R Hydrophilic Introducer Kit
10841268109381Elite HV® R Hydrophilic Introducer Kit
10841268109374Elite HV® R Hydrophilic Introducer Kit
10841268109367Elite HV® R Hydrophilic Introducer Kit
10841268109350Elite HV® R Hydrophilic Introducer Kit
10841268109343Elite HV® R Hydrophilic Introducer Kit
10841268109336Elite HV® R Hydrophilic Introducer Kit
10841268109329Elite HV® R Hydrophilic Introducer Kit
10841268109312Elite HV® R Hydrophilic Introducer Kit
10841268109305Elite HV® R Hydrophilic Introducer Kit
10841268109299Elite HV® R Hydrophilic Introducer Kit

Trademark Results [Elite HV]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ELITE HV
ELITE HV
78691289 3120596 Live/Registered
Galt Medical Corporation
2005-08-12

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