Redial Introducer Set CLI-607-07

GUDID 20841268104406

Redial Introducer Set

GALT MEDICAL CORP.

Haemostasis valve
Primary Device ID20841268104406
NIH Device Record Keyc57ce4f6-b31d-4f42-91b3-7312f139b9b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameRedial Introducer Set
Version Model NumberCLI-607-07
Catalog NumberCLI-607-07
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 Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100841268104402 [Primary]
GS110841268104409 [Package]
Contains: 00841268104402
Package: Shelf Box [5 Units]
In Commercial Distribution
GS120841268104406 [Package]
Contains: 10841268104409
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

[20841268104406]

Ethylene Oxide


[20841268104406]

Ethylene Oxide


[20841268104406]

Ethylene Oxide


[20841268104406]

Ethylene Oxide


[20841268104406]

Ethylene Oxide


[20841268104406]

Ethylene Oxide


[20841268104406]

Ethylene Oxide


[20841268104406]

Ethylene Oxide


[20841268104406]

Ethylene Oxide


[20841268104406]

Ethylene Oxide


[20841268104406]

Ethylene Oxide


[20841268104406]

Ethylene Oxide


[20841268104406]

Ethylene Oxide


[20841268104406]

Ethylene Oxide


[20841268104406]

Ethylene Oxide


[20841268104406]

Ethylene Oxide


Device Entry Metadata

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

On-Brand Devices [Redial Introducer Set]

20841268104406Redial Introducer Set
20841268104390Redial Introducer Set
20841268104383Redial Introducer Set
20841268104376Redial Introducer Set
20841268104369Redial Introducer Set
20841268104352Redial Introducer Set
20841268104345Redial Introducer Set
20841268104338Redial Introducer Set
20841268104321Redial Introducer Set
20841268104314Redial Introducer Set
20841268104307Redial Introducer Set
20841268104291Redial Introducer Set

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.