FDA.reportPublic FDA data

AMPLATZER™

Primary DI
00811806010366
Brand
AMPLATZER™
Company
AGA MEDICAL CORPORATION
Model
9-AVP2-006
Catalog number
9-AVP2-006
Device description
Vascular Plug II
Published
2015-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRDDevice, Vascular, for Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811806010366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811806010366008118060103668118060103660811806010366

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization plug, metallicA sterile, non-bioabsorbable, metal device intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is in the form of an expandable metal scaffold, which once expanded is intended to induce thrombosis and create a blockage; it is typically supplied with instruments dedicated to implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter6Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN A DRY PLACE.
Special Storage Condition, Specify00STORE IN DRY PLACE.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
966215829
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811806014111AMPLATZER™9-TV45X45-14F-1009-TV45X45-14F-1002015-03-09
05415067019127Amplatzer™9-ASD-0049-ASD-0042015-01-27
05415067019134AMPLATZER™9-ASD-0059-ASD-0052015-01-27
05415067019141AMPLATZER™9-ASD-0069-ASD-0062015-01-27
05415067019158AMPLATZER™9-ASD-0079-ASD-0072015-01-27
05415067019165AMPLATZER™9-ASD-0089-ASD-0082015-01-27
05415067019172AMPLATZER™9-ASD-0099-ASD-0092015-01-27
05415067019189AMPLATZER™9-ASD-0109-ASD-0102015-01-27
05415067019196AMPLATZER™9-ASD-0119-ASD-0112015-01-27
05415067019202AMPLATZER™9-ASD-0129-ASD-0122015-01-27
05415067019219Amplatzer™9-ASD-0139-ASD-0132015-01-27
05415067019226Amplatzer™9-ASD-0149-ASD-0142015-01-27
05415067019233Amplatzer™9-ASD-0159-ASD-0152015-01-27
05415067019240Amplatzer™9-ASD-0169-ASD-0162015-01-27
05415067019257Amplatzer™9-ASD-0179-ASD-0172015-01-27
05415067019264Amplatzer™9-ASD-0189-ASD-0182015-01-27
05415067019271Amplatzer™9-ASD-0199-ASD-0192015-01-27
05415067019288Amplatzer™9-ASD-0209-ASD-0202015-01-27
05415067019295Amplatzer™9-ASD-0229-ASD-0222015-01-27
05415067019301Amplatzer™9-ASD-0249-ASD-0242015-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840303712053Prestige Coil SystemBALT USA LLCKRD2026-07-14
00840303712077Prestige Coil SystemBALT USA LLCKRD2026-07-14
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00840303712107Prestige Coil SystemBALT USA LLCKRD2026-07-14
06958698053355Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053362Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053379Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053386Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053393Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053409Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053416Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053423Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053430Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053447Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053454Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053461Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053478Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053485Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053492Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053508Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
07613327635096InZone ISTStryker CorporationKRD2026-07-08
00840303714521Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714538Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714545Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714552Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714569Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
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00840303714590Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714606Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06