DEVICE: VISIGLIDE2 (04953170358227)

Device Identifier (DI) Information

VISIGLIDE2
G-260-3527A
In Commercial Distribution
G-260-3527A
TERUMO CORPORATION
04953170358227
GS1

1
690543319 *Terms of Use
VISIGLIDE2 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

[?]

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

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

[?]
Product Code Product Code Name
OCY Endoscopic guidewire, gastroenterology-urology
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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

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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: Hydrophilic Coating Length : 70mm
Device Size Text, specify: Adaptable type : 0.035 inch
Length: 2700 Millimeter
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Device Record Status

0b3f12ab-2f66-499d-a49d-698bef3f3c1e
October 05, 2018
3
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
54953170358222 5 04953170358227 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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)401-1086
xx@xx.xx
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