Amplatzer™ TorqVue™ 45° x 45° 9-TV45X45-14F-080

GUDID 05415067025906

Delivery Sheath

AGA MEDICAL CORPORATION

Cardiac occluder delivery kit
Primary Device ID05415067025906
NIH Device Record Key703a0ce8-7040-41e9-a59d-6aa0bc0e31f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmplatzer™ TorqVue™ 45° x 45°
Version Model NumberDelivery Sheath
Catalog Number9-TV45X45-14F-080
Company DUNS966215829
Company NameAGA MEDICAL CORPORATION
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 Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Dimensions

Length80 Centimeter
Catheter Gauge14 French
Length80 Centimeter
Catheter Gauge14 French
Length80 Centimeter
Catheter Gauge14 French
Length80 Centimeter
Catheter Gauge14 French
Length80 Centimeter
Catheter Gauge14 French
Length80 Centimeter
Catheter Gauge14 French
Length80 Centimeter
Catheter Gauge14 French
Length80 Centimeter
Catheter Gauge14 French
Length80 Centimeter
Catheter Gauge14 French
Length80 Centimeter
Catheter Gauge14 French
Length80 Centimeter
Catheter Gauge14 French
Length80 Centimeter
Catheter Gauge14 French
Length80 Centimeter
Catheter Gauge14 French
Length80 Centimeter
Catheter Gauge14 French
Length80 Centimeter
Catheter Gauge14 French
Length80 Centimeter
Catheter Gauge14 French
Length80 Centimeter
Catheter Gauge14 French

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067025906 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCATHETER, PERCUTANEOUS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-25

On-Brand Devices [Amplatzer™ TorqVue™ 45° x 45°]

05415067025906Delivery Sheath
05415067025883Delivery Sheath

Trademark Results [Amplatzer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AMPLATZER
AMPLATZER
75263094 2144604 Live/Registered
ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.
1997-03-24

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