Duns Number:092312735
Device Description: CUST SAFETY SHIELD TABLET CUTTER
Catalog Number
-
Brand Name
EZY DOSE
Version/Model Number
80214
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
8f7e90a7-def9-4866-be5d-c9ca5e002bac
Public Version Date
September 08, 2020
Public Version Number
1
DI Record Publish Date
August 31, 2020
Package DI Number
10025715012626
Quantity per Package
250
Contains DI Package
00025715012629
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 |