Duns Number:006959555
Device Description: MEIJER PILL CUTTER AND CRUSHER
Catalog Number
-
Brand Name
MEIJER
Version/Model Number
4320741/67750MJ
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
42aa310e-76ae-40fb-b4f5-622b1b961094
Public Version Date
September 08, 2020
Public Version Number
1
DI Record Publish Date
August 31, 2020
Package DI Number
20713733356873
Quantity per Package
6
Contains DI Package
00713733356879
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 | 37 |
2 | A medical device with a moderate to high risk that requires special controls. | 45 |
U | Unclassified | 1 |