Duns Number:135057938
Device Description: Porter Guidewire 3g, .014" x 195cm
Catalog Number
GWP1403
Brand Name
Porter
Version/Model Number
GWP1403
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
c33f38af-ea90-4f33-93fd-6ce730c11f52
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
September 12, 2016
Package DI Number
10801741067621
Quantity per Package
5
Contains DI Package
00801741067624
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2835 |
| 3 | A medical device with high risk that requires premarket approval | 190 |