Duns Number:079527232
Device Description: THV 1000-21 3F AORTIC BIO 21MM
Catalog Number
-
Brand Name
3f®
Version/Model Number
1000-21
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 29, 2016
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
P060025
Product Code
LWR
Product Code Name
heart-valve, non-allograft tissue
Public Device Record Key
8bbf40b7-434b-46b6-89a3-480b2513fc99
Public Version Date
February 05, 2021
Public Version Number
4
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 | 23 |
| 3 | A medical device with high risk that requires premarket approval | 18 |