DEVICE: GLIDEWIRE (04987350756152)

Device Identifier (DI) Information

GLIDEWIRE
EWSS4520
In Commercial Distribution
RF*PA18453E
TERUMO CORPORATION
04987350756152
GS1

1
690543319 *Terms of Use
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© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35094 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.
Active false
46691 Gastro-urological guidewire, single-use
A sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OCY Endoscopic guidewire, gastroenterology-urology
DQX WIRE, GUIDE, CATHETER
GCJ Laparoscope, general & plastic surgery
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Fragile.Keep away from rain. Keep away from sunlight.
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Clinically Relevant Size

[?]
Size Type Text
Length: 450 Centimeter
Device Size Text, specify: Flexible Tip Length: 3cm
Outer Diameter: 0.51 Millimeter
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Device Record Status

76deed37-af51-4822-9ea0-02a85df414b7
January 19, 2024
7
September 09, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
54987350756157 5 34987350756153 In Commercial Distribution Carton
34987350756153 5 04987350756152 In Commercial Distribution Shelfbox
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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