DEVICE: Artegraft Vascular Graft (00316837000305)

Device Identifier (DI) Information

Artegraft Vascular Graft
AG 745
In Commercial Distribution
AG 745
Artegraft Inc
00316837000305
GS1

1
003683646 *Terms of Use
6mm x 45 cm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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

GMDN Preferred Term Name GMDN Definition
Arteriovenous shunt A surgically-implanted device designed to provide a passage for blood to flow between an artery typically located in an arm, and a peripheral vein, central vein or right atrium, creating a graft fistula that provides blood access for external procedures, especially haemodialysis. It is a synthetic vascular graft/graft assembly with a thin wall and appropriate size (commonly 6 mm diameter) and configuration to facilitate vessel puncturing. It is typically used when it is not possible or convenient to create a direct ateriovenous fistula or for patients who have exhausted peripheral venous access. Disposable devices associated with implantation may be included. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LXA Tissue Graft Of 6mm And Greater
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
N16837 015
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

99c6abf5-d4b7-4859-a7c2-93ee4f0ee18a
July 06, 2018
3
August 29, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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