DEVICE: VISIGLIDE (04953170282744)
Device Identifier (DI) Information
VISIGLIDE
G-240-2527S
In Commercial Distribution
G-240-2527S
TERUMO CORPORATION
G-240-2527S
In Commercial Distribution
G-240-2527S
TERUMO CORPORATION
VISIGLIDE Single Use Guidewire
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? |
---|---|---|---|---|
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OCY | Endoscopic guidewire, gastroenterology-urology |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Fragile. Keep dry. Keep away from sunlight. Stacking limit by 7. |
Clinically Relevant Size
[?]Size Type Text |
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Length: 2700 Millimeter |
Device Size Text, specify: Hydrophilic Coating Length : 70mm |
Device Size Text, specify: Adaptable type : 0.025 inch |
Device Record Status
0ef584cd-bf04-4a8b-a2a4-e9a179d35f7a
July 14, 2022
4
September 09, 2016
July 14, 2022
4
September 09, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
54953170282749 | 5 | 04953170282744 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)401-1086
xx@xx.xx
xx@xx.xx