DEVICE: VISIGLIDE (04953170282881)

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Device Identifier (DI) Information

VISIGLIDE
G-240-3545A
G-240-3545A
TERUMO CORPORATION
04953170282881
GS1
1
VISIGLIDE Single Use Guidewire
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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
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
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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 dry. Keep away from sunlight. Stacking limit by 7.
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Adaptable type : 0.035 inch
Length: 4500 Millimeter
Device Size Text, specify: Hydrophilic Coating Length : 70mm
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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
54953170282886 5 04953170282881 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)

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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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+1(800)401-1086
xx@xx.xx
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