Amplatzer™ 9-ASD-012

GUDID 00811806010090

Septal Occluder

AGA MEDICAL CORPORATION

Cardiac occluder
Primary Device ID00811806010090
NIH Device Record Key059b3414-f24b-44f6-a606-6722d5f30bd5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmplatzer™
Version Model NumberSeptal Occluder
Catalog Number9-ASD-012
Company DUNS966215829
Company NameAGA MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
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
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

Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100811806010090 [Primary]

FDA Product Code

MLVTranscatheter septal occluder

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-09-08

On-Brand Devices [Amplatzer™]

00811806012384Vascular Plug 4
00811806012377Vascular Plug 4
00811806012360Vascular Plug 4
00811806012353Vascular Plug 4
00811806012346Vascular Plug 4
00811806012087Delivery Sheath
00811806011851VSD Muscular Occluder
00811806011844VSD Muscular Occluder
00811806011837VSD Muscular Occluder
00811806011820VSD Muscular Occluder
00811806011813VSD Muscular Occluder
00811806011806VSD Muscular Occluder
00811806011790VSD Muscular Occluder
00811806011783VSD Muscular Occluder
00811806011530Sizing Balloon II
00811806011523Sizing Balloon II
00811806011516Sizing Balloon II
00811806011264Duct Occluder II
00811806011240Duct Occluder II
00811806011233Duct Occluder II
00811806011219Duct Occluder II
00811806011202Duct Occluder II
00811806011189Duct Occluder II
00811806011172Duct Occluder II
00811806011141Duct Occluder
00811806011127Duct Occluder
00811806011110Duct Occluder
00811806011103Duct Occluder
00811806010748Guidewire
00811806010731Guidewire
00811806010724Guidewire
00811806010717Guidewire
00811806010649Exchange System
00811806010632Exchange System
00811806010625Exchange System
00811806010335Sizing Plate
00811806010311MF Septal Occluder Cribriform
00811806010304MF Septal Occluder Cribriform
00811806010298MF Septal Occluder Cribriform
00811806010281MF Septal Occluder Cribriform
00811806010267Septal Occluder
00811806010250Septal Occluder
00811806010243Septal Occluder
00811806010236Septal Occluder
00811806010229Septal Occluder
00811806010212Septal Occluder
00811806010205Septal Occluder
00811806010199Septal Occluder
00811806010182Septal Occluder
00811806010175Septal Occluder

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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