Duns Number:063997360
Device Description: LDR Tablet Cutter with Safety Shield 1 ea
Catalog Number
3687456
Brand Name
LEADER
Version/Model Number
3687456
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OHY
Product Code Name
Pill crusher/cutter
Public Device Record Key
9f3183c7-ef56-4f38-a46d-c33ac63d49e1
Public Version Date
July 23, 2020
Public Version Number
2
DI Record Publish Date
October 21, 2019
Package DI Number
50096295113704
Quantity per Package
12
Contains DI Package
30096295113700
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |