Duns Number:079527232
Device Description: SIZER SET 578 OPHV AP-AP360 NITINOL26LCE
Catalog Number
-
Brand Name
Medtronic Open Pivot™
Version/Model Number
578
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DTI
Product Code Name
SIZER, HEART-VALVE, PROSTHESIS
Public Device Record Key
963e9de6-77b0-4f4b-b274-e45b8d32fcbd
Public Version Date
June 14, 2021
Public Version Number
1
DI Record Publish Date
June 06, 2021
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 | 23 |
3 | A medical device with high risk that requires premarket approval | 18 |