Radial Artery Access Introducer Set CLI-404-05

GUDID 20841268104031

Radial Artery Access Introducer Set

GALT MEDICAL CORP.

Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve
Primary Device ID20841268104031
NIH Device Record Key8c47b24b-2db9-4d9f-a8ff-56bd507bee6b
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadial Artery Access Introducer Set
Version Model NumberCLI-404-05
Catalog NumberCLI-404-05
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 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
GS100841268104037 [Primary]
GS110841268104034 [Package]
Contains: 00841268104037
Package: Shelf Box [5 Units]
In Commercial Distribution
GS120841268104031 [Package]
Contains: 10841268104034
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

[20841268104031]

Ethylene Oxide


[20841268104031]

Ethylene Oxide


[20841268104031]

Ethylene Oxide


[20841268104031]

Ethylene Oxide


[20841268104031]

Ethylene Oxide


[20841268104031]

Ethylene Oxide


[20841268104031]

Ethylene Oxide


[20841268104031]

Ethylene Oxide


[20841268104031]

Ethylene Oxide


[20841268104031]

Ethylene Oxide


[20841268104031]

Ethylene Oxide


[20841268104031]

Ethylene Oxide


[20841268104031]

Ethylene Oxide


[20841268104031]

Ethylene Oxide


[20841268104031]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-05
Device Publish Date2018-02-23

On-Brand Devices [Radial Artery Access Introducer Set]

20841268104130Radial Artery Access Introducer Set
20841268104123Radial Artery Access Introducer Set
20841268104116Radial Artery Access Introducer Set
20841268104109Radial Artery Access Introducer Set
20841268104093Radial Artery Access Introducer Set
20841268104086Radial Artery Access Introducer Set
20841268104079Radial Artery Access Introducer Set
20841268104062Radial Artery Access Introducer Set
20841268104055Radial Artery Access Introducer Set
20841268104048Radial Artery Access Introducer Set
20841268104031Radial Artery Access Introducer Set
20841268104024Radial Artery Access Introducer Set
20841268104017Radial Artery Access Introducer Set
20841268104000Radial Artery Access Introducer Set
20841268103997Radial Artery Access Introducer Set
20841268103980Radial Artery Access Introducer Set
20841268103973Radial Artery Access Introducer Set
20841268103966Radial Artery Access Introducer Set

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