DEVICE: Cruzar Medsystems Inc. (00860554000358)

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Device Identifier (DI) Information

Cruzar Medsystems Inc.
CM-3800

CRUZAR MEDSYSTEMS INC
00860554000358
GS1
1
The Houdini Catheter is a single use, dual-lumen intravascular catheter intended for percutaneous use. The Houdini Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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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
Vascular guide-catheter, single-use A sterile, flexible, single-lumen tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter or lead (e.g., pacing lead, balloon dilatation catheter) through its lumen, within the vascular system. It may be rigid or flexible, non-steerable or steerable, and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, and is not a microcatheter (i.e., not intended to access superselective small vessels). It may include a disposable percutaneous introduction set. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DQY Catheter, Percutaneous
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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
Pressure: 176 Pound per Square Inch
Lumen/Inner Diameter: .035 Inch
Length: 100 Centimeter
Device Size Text, specify: 8mm x 2cm Balloon
Catheter Gauge: 6 French
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Device Status

In Commercial Distribution
August 26, 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
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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