DEVICE: SVDS300 SAPHENOUS VEIN DISTENTION SYSTEM - 300mmHg (05391530750066)

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Device Identifier (DI) Information

SVDS300 SAPHENOUS VEIN DISTENTION SYSTEM - 300mmHg
SVDS300
FD-1004
DMC MEDICAL LIMITED
05391530750066
GS1
1
Saphenous Vein Distention System - 300mmHg - Sterile
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
Yes
No
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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
Vein irrigation/distention set A collection of devices used for the distention and irrigation of veins (e.g., saphenous) for testing and clearance prior to removal of a section for use as a coronary or peripheral bypass graft. It is also used for vein distention to facilitate ligating side branches in the vein. It typically consists of a standard syringe (e.g., 60 ml), various stainless steel devices (pin, spring, rod), and plastic rings and balls that are used during the process. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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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 Status

In Commercial Distribution
August 10, 2016

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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
05391530750080 3 05391530750073 In Commercial Distribution
05391530750073 5 05391530750066 In Commercial Distribution
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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
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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