Redial Introducer Set CLI-604-05

GUDID 20841268104291

Redial 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 Haemostasis valve
Primary Device ID20841268104291
NIH Device Record Keya39bacd6-0bd2-41f9-9753-c3c954d32f93
Commercial Distribution StatusIn Commercial Distribution
Brand NameRedial Introducer Set
Version Model NumberCLI-604-05
Catalog NumberCLI-604-05
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
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
GS100841268104297 [Primary]
GS110841268104294 [Package]
Contains: 00841268104297
Package: Shelf Box [5 Units]
In Commercial Distribution
GS120841268104291 [Package]
Contains: 10841268104294
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

[20841268104291]

Ethylene Oxide


[20841268104291]

Ethylene Oxide


[20841268104291]

Ethylene Oxide


[20841268104291]

Ethylene Oxide


[20841268104291]

Ethylene Oxide


[20841268104291]

Ethylene Oxide


[20841268104291]

Ethylene Oxide


[20841268104291]

Ethylene Oxide


[20841268104291]

Ethylene Oxide


[20841268104291]

Ethylene Oxide


[20841268104291]

Ethylene Oxide


[20841268104291]

Ethylene Oxide


[20841268104291]

Ethylene Oxide


[20841268104291]

Ethylene Oxide


[20841268104291]

Ethylene Oxide


[20841268104291]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-05
Device Publish Date2018-02-26

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20841268104338Redial Introducer Set
20841268104321Redial Introducer Set
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20841268104307Redial Introducer Set
20841268104291Redial Introducer Set

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