Duns Number:043537671
Device Description: HYPODERMOCLYSIS PREP KIT
Catalog Number
-
Brand Name
Stradis Medical, LLC.
Version/Model Number
SUBIMHYP1000
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
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
86e45a6e-96e2-40ba-8eaa-9363a46acb97
Public Version Date
July 03, 2020
Public Version Number
1
DI Record Publish Date
June 25, 2020
Package DI Number
M752SUBIMHYP10005
Quantity per Package
50
Contains DI Package
M752SUBIMHYP10000
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 |