Tearaway Sheath Introducer INT-117-16

GUDID 10841268109640

Tearaway Sheath Introducer

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
Primary Device ID10841268109640
NIH Device Record Key31b823ec-9eb2-4811-badf-2447f4bb4f0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTearaway Sheath Introducer
Version Model NumberINT-117-16
Catalog NumberINT-117-16
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
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
Phone800-639-2800
Emailcustomerservice@galtneedletech.com

Device Dimensions

Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100841268109643 [Primary]
GS110841268109640 [Package]
Contains: 00841268109643
Package: Shelf Box [10 Units]
In Commercial Distribution
GS120841268109647 [Package]
Package: Shipper Box [100 Units]
In Commercial Distribution

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

[10841268109640]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-08
Device Publish Date2021-10-29

Devices Manufactured by GALT MEDICAL CORP.

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10841268109824 - Elite Transitionless Micro-Introducer Kit2022-08-23 Elite Transitionless Micro-Introducer Kit
10841268109831 - Elite Transitionless Micro-Introducer Kit2022-08-23 Elite Transitionless Micro-Introducer Kit
10841268109848 - Elite Transitionless Micro-Introducer Kit2022-08-23 Elite Transitionless Micro-Introducer Kit
10841268109855 - Elite Transitionless Micro-Introducer Kit2022-08-23 Elite Transitionless Micro-Introducer Kit
10841268109862 - Elite Transitionless Micro-Introducer Kit2022-08-23 Elite Transitionless Micro-Introducer Kit
10841268109879 - Elite Transitionless Micro-Introducer Kit2022-08-23 Elite Transitionless Micro-Introducer Kit
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