Duns Number:092312735
Device Description: Pill Crusher
Catalog Number
-
Brand Name
Remind n Time
Version/Model Number
70408AMZ
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
aa5685a4-fe93-4ec2-a4ae-e3a5badbd3df
Public Version Date
November 02, 2021
Public Version Number
1
DI Record Publish Date
October 25, 2021
Package DI Number
10077602775275
Quantity per Package
36
Contains DI Package
00077602775278
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
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 |