DEVICE: GLIDEWIRE (04987350755919)

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Device Identifier (DI) Information

GLIDEWIRE
EWSS4535
RF*PS35453E
TERUMO CORPORATION
04987350755919
GS1
1
RADIFOCUS GLIDEWIRE
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Cardiac/peripheral vascular guidewire, single-use A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.
General-purpose non-vascular guidewire A non-dedicated metal wire designed to position a catheter or similar interventional device (e.g., a dilator or an endoscope) within a lumen of the gastrointestinal (GI) tract, the tracheobronchial tree, and the urinary tract (i.e., not dedicated to either clinical application). Typically, the catheter is advanced over the wire after the wire has been manoeuvred to a treatment site (e.g., site of stent-placement). It is available in a variety of diameters and lengths, may have fluoroscopic markers, or be fitted with an introducer for entering the working channel of the catheter or other interventional device. This is a single-use device.
Endoscopic guidewire, single-use A sterile device intended to be inserted through the working channel of a compatible flexible endoscope to assist in the insertion/positioning of an endoscope or endotherapy devices (e.g., stent-placement devices, electrosurgical devices, or catheters) during diagnostic and therapeutic endoscopy, typically within the gastrointestinal (GI) tract. It is made of a flexible metal coil or wire coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
OCY Endoscopic guidewire, gastroenterology-urology
DQX WIRE, GUIDE, CATHETER
GCJ Laparoscope, general & plastic surgery
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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: Fragile.Keep away from rain. Keep away from sunlight.
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Flexible Tip Length: 3cm
Length: 450 Centimeter
Outer Diameter: 0.89 Millimeter
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Device Status

In Commercial Distribution
September 09, 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
34987350755910 5 04987350755919 In Commercial Distribution Shelfbox
54987350755914 5 34987350755910 In Commercial Distribution Carton
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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
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)283-7866
tmccustomer.admin@terumomedical.com
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