Duns Number:092312735
Device Description: DELUXE CUT N CRUSH
Catalog Number
-
Brand Name
Ezy Dose
Version/Model Number
67750/67750AZ/HK67750/67750CA
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
cbca6dd4-af68-4e42-863b-6b438b899327
Public Version Date
December 02, 2020
Public Version Number
1
DI Record Publish Date
November 24, 2020
Package DI Number
20025715677501
Quantity per Package
6
Contains DI Package
00025715677507
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |