Duns Number:134139174
Device Description: Physio Flex Annuloplasty Ring
Catalog Number
5300M24
Brand Name
Physio Flex Annuloplasty Ring
Version/Model Number
5300
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K192762
Product Code
KRH
Product Code Name
Ring, Annuloplasty
Public Device Record Key
a8e67233-2ce3-4bd0-a807-541bbfde7aa9
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
February 27, 2020
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 643 |
| 3 | A medical device with high risk that requires premarket approval | 212 |