DEVICE: USE® 0.035" PTA OTW Catheter (06091403503063)

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Device Identifier (DI) Information

USE® 0.035" PTA OTW Catheter
USE356_00-20B

NATEC MEDICAL LTD
06091403503063
GS1
1
USE® 0.035" PTA OTW Catheter, 6.00x20mm /Shaft length 130cm
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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
Handling Environment Temperature: between 15 and 40 Degrees Celsius
Special Storage Condition, Specify: keep dry and Keep away from sunlight
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Clinically Relevant Size

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Size Type Text
Length: 20.0 Millimeter
Outer Diameter: 6.00 Millimeter
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Device Status

In Commercial Distribution
October 07, 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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+2304663054
info@natec-medical.com
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