Duns Number:043537671
Device Description: Central Line Insertion Tray
Catalog Number
-
Brand Name
Stradis Medical, LLC.
Version/Model Number
HCT8249CP-3
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
OFF
Product Code Name
Central Venous Catheter Tray
Public Device Record Key
004b6a42-8ef7-4ff9-8a8f-74b69fe97ea5
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
June 24, 2020
Package DI Number
M752HCT8249CP35
Quantity per Package
12
Contains DI Package
M752HCT8249CP30
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
OUTER BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |