Duns Number:964569052
Device Description: MULTI-LINK 8 LL Coronary Stent System 4.0 mm x 33 mm / Rapid-Exchange
Catalog Number
1012380-33
Brand Name
MULTI-LINK 8
Version/Model Number
1012380-33
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
525ee0ad-5b41-4fb7-a076-d3145cc39347
Public Version Date
October 07, 2019
Public Version Number
4
DI Record Publish Date
October 27, 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 |