DEVICE: AMPLATZER™ (00811806010397)

Device Identifier (DI) Information

AMPLATZER™
9-AVP2-012
In Commercial Distribution
9-AVP2-012
AGA MEDICAL CORPORATION
00811806010397
GS1

1
966215829 *Terms of Use
Vascular Plug II
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Device Characteristics

MR Conditional
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Non-neurovascular embolization plug, metallic A 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.
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FDA Product Code

[?]
Product Code Product Code Name
KRD Device, Vascular, for Promoting Embolization
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: STORE IN DRY PLACE.
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 12 Millimeter
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Device Record Status

1fae8c07-1ea0-423f-a04d-b2183ff16dd4
February 05, 2021
4
July 21, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
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