Duns Number:066886996
Device Description: This expert designed cup pill crusher combines an ergonomic handle design with a unique bu This expert designed cup pill crusher combines an ergonomic handle design with a unique buffering and grinding motion to deliver highly effective pill crushing with minimal manual effort. Very easy to use. The unique anvil design working with the cup platform delivers both a crushing and grinding with maximum crushing effort. No tapping or pounding. A two cup method is used to reduce the chance of cross-contamination and particulate powder. Accommodates a range of cup sizes. The 1 oz. plastic cups are recommended.
Catalog Number
-
Brand Name
Maxpert Medical MaxCrush
Version/Model Number
M200
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
f742605f-0fe7-45c1-975c-e6dd3feb0bcc
Public Version Date
September 08, 2022
Public Version Number
4
DI Record Publish Date
December 19, 2017
Package DI Number
10852359007011
Quantity per Package
8
Contains DI Package
00852359007014
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |