Duns Number:066886996
Device Description: The MAXSPLIT Pill Splitter with Puncher is crafted of quality and durable FDA compliant fo The MAXSPLIT Pill Splitter with Puncher is crafted of quality and durable FDA compliant food grade plastic ensures that medications are contacting high quality, safe plastic and that the splitter is going to last over repeated use. When opening MAXSPLIT™, you will find an ergonomic U-shaped holder that allows pills of various sizes, shapes and thicknesses to be easily positioned and split safely and accurately. This U-shaped opening assists in proper pill alignment and the rubber insert holds pill in place while splitting to help ensure an accurate cut.
Catalog Number
-
Brand Name
MAXSPLIT
Version/Model Number
BMS01B
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
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
b15a71cd-72a7-4850-8f6d-875a37da0e6c
Public Version Date
September 28, 2022
Public Version Number
3
DI Record Publish Date
October 26, 2020
Package DI Number
10852359007141
Quantity per Package
60
Contains DI Package
00852359007144
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 |