Duns Number:092312735
Device Description: SAFETY SHIELD PILL CUTTER
Catalog Number
-
Brand Name
Ezy Dose
Version/Model Number
67572/67856/67856AZ/HK67856/67856UHC
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
376b5a00-316e-4ed1-be61-8fe817e5ae7e
Public Version Date
December 02, 2020
Public Version Number
1
DI Record Publish Date
November 24, 2020
Package DI Number
20025715024312
Quantity per Package
6
Contains DI Package
00025715678566
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER
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 |