Micro-Introducer Set INT-112-10

GUDID 20841268106974

Micro-Introducer Set

GALT MEDICAL CORP.

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable
Primary Device ID20841268106974
NIH Device Record Key889b16a1-8429-427a-9803-47d4c6b29fc0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicro-Introducer Set
Version Model NumberINT-112-10
Catalog NumberINT-112-10
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
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com
Phone800-639-2800
Emailcustomersrvice@galtneedletech.com

Device Dimensions

Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100841268106970 [Primary]
GS110841268106977 [Package]
Contains: 00841268106970
Package: Shelf Box [5 Units]
In Commercial Distribution
GS120841268106974 [Package]
Contains: 10841268106977
Package: Shipper Box [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DREDilator, Vessel, For Percutaneous Catheterization

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

[20841268106974]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2017-08-09

On-Brand Devices [Micro-Introducer Set]

20841268106974Micro-Introducer Set
20841268106967Micro-Introducer Set
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.