Duns Number:071595540
Device Description: XWIRE Next Generation Guidewire, 450cm, Stiff Wire, Torquable Angled Tip
Catalog Number
035450AS
Brand Name
XWIRE
Version/Model Number
035450AS
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
K011759,K011759,K011759
Product Code
OCY
Product Code Name
Endoscopic guidewire, gastroenterology-urology
Public Device Record Key
a8faef54-cd47-4562-a72a-35dc72c3b5aa
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10653405053941
Quantity per Package
3
Contains DI Package
20653405053948
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |