Duns Number:174262477
Catalog Number
-
Brand Name
STRADIS HEALTHCARE
Version/Model Number
681-275 R3
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
25a4865f-4752-48b2-b462-9d7ecd1e3c96
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
March 18, 2022
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 | 1226 |
2 | A medical device with a moderate to high risk that requires special controls. | 1431 |
U | Unclassified | 10 |