Duns Number:025460908
Device Description: SAFETY SHIELD PILL SPLITTER
Catalog Number
NON138700R
Brand Name
Medline
Version/Model Number
NON138700R
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)
-
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
e0ee60fa-7cae-4b58-b30b-83467cff5dcc
Public Version Date
November 19, 2021
Public Version Number
1
DI Record Publish Date
November 11, 2021
Package DI Number
10193489083002
Quantity per Package
72
Contains DI Package
00193489083005
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 |