Duns Number:149818952
Device Description: Guidewire
Catalog Number
C12359
Brand Name
PressureWire™
Version/Model Number
X
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
DQX
Product Code Name
WIRE, GUIDE, CATHETER
Public Device Record Key
55b1ea26-6fc7-48ba-98ae-1cb0d78f170b
Public Version Date
September 21, 2020
Public Version Number
6
DI Record Publish Date
August 19, 2016
Package DI Number
15415067025729
Quantity per Package
5
Contains DI Package
05415067025722
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 70 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1429 |
| 3 | A medical device with high risk that requires premarket approval | 736 |