Duns Number:174262477
Device Description: Ready Sharp KETOROLAC
Catalog Number
-
Brand Name
Stradis Medical, LLC.
Version/Model Number
TRNRSS3655
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"
-
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
LRO
Product Code Name
General Surgery Tray
Public Device Record Key
bc56be44-6938-4d65-8a29-597f48dce420
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
February 09, 2018
Package DI Number
M752TRNRSS36555
Quantity per Package
20
Contains DI Package
M752TRNRSS36550
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 | 1226 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1431 |
| U | Unclassified | 10 |