Duns Number:006961700
Device Description: 094 01 0632, Pill Cutter with protective shield
Catalog Number
-
Brand Name
up & up
Version/Model Number
094 01 0632 (67856TG3)
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
12efd2a0-df07-4c60-a538-f10fc8ac8657
Public Version Date
February 26, 2021
Public Version Number
2
DI Record Publish Date
September 16, 2020
Package DI Number
20025715034908
Quantity per Package
6
Contains DI Package
00025715003306
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |
| U | Unclassified | 12 |