Duns Number:964569052
Device Description: MULTI-LINK OTW VISION Coronary Stent System 4.00 mm x 15 mm
Catalog Number
1010145-15
Brand Name
MULTI-LINK VISION
Version/Model Number
1010145-15
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 16, 2022
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
MAF
Product Code Name
STENT, CORONARY
Public Device Record Key
25939a5a-a9a2-400f-8ae9-a44f4bd78042
Public Version Date
January 06, 2020
Public Version Number
4
DI Record Publish Date
November 20, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 964 |
| 3 | A medical device with high risk that requires premarket approval | 775 |