DEVICE: Stroke Fast Pack (07613327126297)

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Device Identifier (DI) Information

Stroke Fast Pack
M0033PK62523001
3PK62523001
Stryker Corporation
07613327126297
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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
Thrombectomy suction catheter A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) typically achieved with the use of an included syringe(s) attached to the proximal end of the catheter, or connection to a dedicated suction pump system. Collection baskets may also be included to obtain filtered blood specimens for analyses. This is a single-use device.
Intravascular microflow catheter A sterile, small-diameter, flexible tube designed for the controlled infusion of agents/fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including neuro, peripheral, or coronary vasculature) for angiography and treatment, and the delivery of embolic devices into tortuous or superselective anatomy. Also known as a continuous flush catheter, it may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is typically used with a microflow infusion system which provides the energy for its application. This is a single-use device.
Vascular guide-catheter, single-use A sterile flexible tube intended to be used for the percutaneous transluminal passage and placement of guidewires and/or diagnostic/interventional devices (e.g., pacing leads, balloon dilatation catheter, stent and delivery system, or embolization device) within the vascular system. The guide catheter 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, multi-purpose, hockey stick, renal double curve); it typically has radiopaque markers so that it can be fluoroscopically tracked. It may include disposable introduction devices (e.g., needle, guidewire, dilator). This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
No Product Codes
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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
Special Storage Condition, Specify: Store in cool, dry, dark place.
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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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+1(855)916-3876
NVCustomerService@stryker.com
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