Duns Number:066886996
Device Description: MAXGRIND™ is a revolutionary, high-quality twist pill crusher and grinder featuring an erg MAXGRIND™ is a revolutionary, high-quality twist pill crusher and grinder featuring an ergonomic, easy-to grip and twist design.This hand-held twist pill crusher allows medication to be delivered in two ways: into the bottom serving cup or crushed directly into a disposable medication cup.
Catalog Number
-
Brand Name
MAXGRIND
Version/Model Number
BMG01B
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
e46fa20f-1fea-46a7-8ed5-4bf51280d8ee
Public Version Date
August 15, 2022
Public Version Number
3
DI Record Publish Date
October 05, 2018
Package DI Number
10852359007134
Quantity per Package
20
Contains DI Package
00852359007137
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PKG
| 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 |