Duns Number:006261481
Device Description: MHV 501DM22 AP MITRAL
Catalog Number
-
Brand Name
Open Pivot™
Version/Model Number
501DM22
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 21, 2019
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
P990046
Product Code
LWQ
Product Code Name
HEART-VALVE, MECHANICAL
Public Device Record Key
0b8d6b24-58ac-4e45-bdb9-360bd98ba3d5
Public Version Date
September 12, 2022
Public Version Number
5
DI Record Publish Date
September 23, 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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |