Duns Number:174262477
Catalog Number
-
Brand Name
Stradis Medical, LLC.
Version/Model Number
F5PG014.01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
FTN
Product Code Name
Plastic Surgery And Accessories Kit
Public Device Record Key
0267d61e-f9c0-43f1-b898-30037cc188a6
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
June 01, 2022
Package DI Number
M752F5PG014011
Quantity per Package
30
Contains DI Package
M752F5PG014010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1226 |
2 | A medical device with a moderate to high risk that requires special controls. | 1431 |
U | Unclassified | 10 |