Duns Number:149818952
Device Description: Guidewires
Catalog Number
404573
Brand Name
GuideRight™
Version/Model Number
404573
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 29, 2018
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
088d4ba1-3962-49d1-a1de-2806c8cea169
Public Version Date
September 21, 2020
Public Version Number
5
DI Record Publish Date
June 23, 2015
Package DI Number
15414734013236
Quantity per Package
5
Contains DI Package
05414734013239
Package Discontinue Date
June 29, 2018
Package Status
Not 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 |