Duns Number:964569052
Device Description: MULTI-LINK MINI VISION Coronary Stent and Stent Delivery System 2.25 mm x 08 mm / Over-The MULTI-LINK MINI VISION Coronary Stent and Stent Delivery System 2.25 mm x 08 mm / Over-The-Wire
Catalog Number
1010153-08
Brand Name
MULTI-LINK MINI VISION
Version/Model Number
1010153-08
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 21, 2018
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
bde0fd82-5a26-4c3c-843a-89facf8c30a5
Public Version Date
October 07, 2019
Public Version Number
4
DI Record Publish Date
November 21, 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 |