Elite HV® F Introducer Kit CLI-114-15

GUDID 10841268109534

Elite HV® F Introducer Kit

GALT MEDICAL CORP.

Haemostasis valve
Primary Device ID10841268109534
NIH Device Record Keyebd445fd-4db4-4178-9e12-d1c9a55b4324
Commercial Distribution StatusIn Commercial Distribution
Brand NameElite HV® F Introducer Kit
Version Model NumberCLI-114-15
Catalog NumberCLI-114-15
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
Phone800-639-2800
Emailcustomerservice@galtneedletech.com

Device Dimensions

Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100841268109537 [Primary]
GS110841268109534 [Package]
Contains: 00841268109537
Package: Shelf Box [10 Units]
In Commercial Distribution
GS120841268109531 [Package]
Package: Shipper Box [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10841268109534]

Ethylene Oxide


[10841268109534]

Ethylene Oxide


[10841268109534]

Ethylene Oxide


[10841268109534]

Ethylene Oxide


[10841268109534]

Ethylene Oxide


[10841268109534]

Ethylene Oxide


[10841268109534]

Ethylene Oxide


[10841268109534]

Ethylene Oxide


[10841268109534]

Ethylene Oxide


[10841268109534]

Ethylene Oxide


[10841268109534]

Ethylene Oxide


[10841268109534]

Ethylene Oxide


[10841268109534]

Ethylene Oxide


[10841268109534]

Ethylene Oxide


[10841268109534]

Ethylene Oxide


[10841268109534]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-14
Device Publish Date2021-06-04

On-Brand Devices [Elite HV® F Introducer Kit]

10841268109589Elite HV® F Introducer Kit
10841268109572Elite HV® F Introducer Kit
10841268109565Elite HV® F Introducer Kit
10841268109558Elite HV® F Introducer Kit
10841268109541Elite HV® F Introducer Kit
10841268109534Elite HV® F Introducer Kit
10841268109527Elite HV® F Introducer Kit
10841268109510Elite HV® F Introducer Kit
10841268109503Elite HV® F Introducer Kit
10841268109497Elite HV® F 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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