DEVICE: CROSSTELLA OTW (04540778161917)

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Device Identifier (DI) Information

CROSSTELLA OTW
BD-F25100LW
BD-F25100LW
KANEKA CORPORATION
04540778161917
GS1
1
CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46 mm).
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Device Characteristics

Labeling does not contain MRI Safety Information
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
Peripheral angioplasty balloon catheter, basic A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include microsurgical blades (atherotomes) to score the plaque. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LIT Catheter, Angioplasty, Peripheral, Transluminal
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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 a cool, dry, dark place. Avoid exposure to water, direct sunlight.
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Maximum Guidewire Diameter; 0.018 inch
Device Size Text, specify: Compatible Sheath Diameter; 4 Fr
Device Size Text, specify: Rated Burst Pressure; 14 atm
Device Size Text, specify: Nominal Pressure; 8 atm
Device Size Text, specify: Shaft Diameter; 3.9 Fr
Device Size Text, specify: Catheter Working Length; 1500 mm
Device Size Text, specify: Balloon Length; 100 mm
Device Size Text, specify: Balloon Diameter; 2.5 mm
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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
Yes
Yes
No
No CLOSE

Customer Contact

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800-888-3786
tmccustomer.admin@terumomedical.com
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