Duns Number:025460908
Device Description: CUTTER/CRUSHER, PILL, BLUE
Catalog Number
NON137000R
Brand Name
Medline
Version/Model Number
NON137000R
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"
Yes
For Single-Use
Yes
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
NXB
Product Code Name
Dispenser, solid medication
Public Device Record Key
d86cd4ac-2483-40ce-abd5-ad0193f4a0ac
Public Version Date
April 06, 2022
Public Version Number
1
DI Record Publish Date
March 29, 2022
Package DI Number
10193489102499
Quantity per Package
24
Contains DI Package
00193489102492
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 | 38540 |
2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
3 | A medical device with high risk that requires premarket approval | 2 |
U | Unclassified | 7 |