Duns Number:038000253
Device Description: 0.035" (0.89MM) X 45CM0.035" (0. J/FLEX GUIDEWIREJ/FLEX GUIDEWIRE
Catalog Number
MC45J
Brand Name
CARDIOVASCULAR SPRING GUIDESCARDIOVASCULAR SPRING GUIDES
Version/Model Number
MC45J
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 29, 2021
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"
Yes
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
47551cfe-c538-4622-ba32-d5f6e361e922
Public Version Date
February 03, 2021
Public Version Number
2
DI Record Publish Date
October 24, 2018
Package DI Number
50884908029371
Quantity per Package
4
Contains DI Package
30884908029377
Package Discontinue Date
January 29, 2021
Package Status
Not 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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |