Micro-Access Redial Introducer Set CLI-600-07

GUDID 20841268104192

Micro-Access 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 ID20841268104192
NIH Device Record Key44d36a32-f5fe-4d51-9171-d0978579eb25
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicro-Access Redial Introducer Set
Version Model NumberCLI-600-07
Catalog NumberCLI-600-07
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
GS100841268104198 [Primary]
GS110841268104195 [Package]
Contains: 00841268104198
Package: Shelf Box [5 Units]
In Commercial Distribution
GS120841268104192 [Package]
Contains: 10841268104195
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

[20841268104192]

Ethylene Oxide


[20841268104192]

Ethylene Oxide


[20841268104192]

Ethylene Oxide


[20841268104192]

Ethylene Oxide


[20841268104192]

Ethylene Oxide


[20841268104192]

Ethylene Oxide


[20841268104192]

Ethylene Oxide


[20841268104192]

Ethylene Oxide


[20841268104192]

Ethylene Oxide


[20841268104192]

Ethylene Oxide


[20841268104192]

Ethylene Oxide


[20841268104192]

Ethylene Oxide


[20841268104192]

Ethylene Oxide


[20841268104192]

Ethylene Oxide


[20841268104192]

Ethylene Oxide


[20841268104192]

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 [Micro-Access Redial Introducer Set]

20841268104284Micro-Access Redial Introducer Set
20841268104277Micro-Access Redial Introducer Set
20841268104260Micro-Access Redial Introducer Set
20841268104253Micro-Access Redial Introducer Set
20841268104246Micro-Access Redial Introducer Set
20841268104239Micro-Access Redial Introducer Set
20841268104222Micro-Access Redial Introducer Set
20841268104215Micro-Access Redial Introducer Set
20841268104208Micro-Access Redial Introducer Set
20841268104192Micro-Access Redial Introducer Set
20841268104185Micro-Access Redial Introducer Set
20841268104178Micro-Access Redial Introducer Set

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