DEVICE: NeoWire (00857834006506)

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Device Identifier (DI) Information

NeoWire
SP-4089-500

NEOMETRICS, INC.
00857834006506
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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
Cardiac guidewire, single-use A long, coiled, sterile wire intended to be percutaneously placed into the vasculature, typically via the femoral artery, to function as a guide for the introduction, positioning, and/or operation of a cardiac catheter or a pacing lead into the ventricles or vessels of the heart. It is typically made of stainless steel, with or without coating (coating facilitates movement), and is available in a variety of distal tip designs. It is used during percutaneous transluminal coronary angioplasty (PTCA) and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DQX Wire, Guide, Catheter
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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
September 21, 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
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
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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