Duns Number:690543319
Device Description: VISIGLIDE2 Single Use Guidewire
Catalog Number
G-260-3545A
Brand Name
VISIGLIDE2
Version/Model Number
G-260-3545A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OCY
Product Code Name
Endoscopic guidewire, gastroenterology-urology
Public Device Record Key
65de879b-66cf-4f6d-a5bc-a273afa61335
Public Version Date
July 14, 2022
Public Version Number
4
DI Record Publish Date
September 09, 2016
Package DI Number
54953170358260
Quantity per Package
5
Contains DI Package
04953170358265
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 364 |
| 3 | A medical device with high risk that requires premarket approval | 29 |