Duns Number:092312735
Device Description: PILL CRUSHER 6/72PILL CRUSHER 6/72WEGMANS PILL CRUSHER 6/72
Catalog Number
-
Brand Name
Acu-Life
Version/Model Number
PC12/HKPC12/PC12WE
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
ddf90eae-f0c9-49e8-bf4e-cb04a08d0f02
Public Version Date
September 09, 2020
Public Version Number
1
DI Record Publish Date
September 01, 2020
Package DI Number
20079573000162
Quantity per Package
6
Contains DI Package
00079573009161
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 |