DEVICE: CELLO™, Balloon Guide Catheter (04544050093491)

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Device Identifier (DI) Information

CELLO™, Balloon Guide Catheter
9F
1510590
FUJI SYSTEMS CORPORATION
04544050093491
GS1
1
The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
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Device Characteristics

MR Unsafe
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
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
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
No Device Sizes
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Device Status

In Commercial Distribution
September 24, 2015

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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)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
No
Yes CLOSE

Customer Contact

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949-837-3700
XX@XX.XX
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