Duns Number:043537671
Device Description: Hazardous Drug Spill Kit
Catalog Number
-
Brand Name
Stradis Medical, LLC
Version/Model Number
IM1264
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 12, 2019
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
-
Product Code Name
-
Public Device Record Key
3d59a891-9f87-4b86-aa84-4d9a95ad886d
Public Version Date
July 23, 2019
Public Version Number
2
DI Record Publish Date
May 29, 2019
Package DI Number
M752IM12645
Quantity per Package
6
Contains DI Package
M752IM12640
Package Discontinue Date
July 12, 2019
Package Status
Not 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 |