Duns Number:092312735
Device Description: PILL SPLITTER 12/144
Catalog Number
-
Brand Name
Acu-Life
Version/Model Number
PS12E
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
14f59f86-d0b9-4cfb-a17a-f776c32a5743
Public Version Date
September 18, 2020
Public Version Number
1
DI Record Publish Date
September 10, 2020
Package DI Number
10079573011154
Quantity per Package
12
Contains DI Package
00079573011157
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
bag
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 |