Duns Number:002397347
Device Description: OMNICAN 100 1 ML INSULIN U-100 30GX8
Catalog Number
9151133US
Brand Name
Omnican®
Version/Model Number
9151133US
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 20, 2017
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
FMF
Product Code Name
Syringe, piston
Public Device Record Key
762042c7-054f-496e-8d92-a2be54ce5967
Public Version Date
March 16, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
04046963456795
Quantity per Package
24
Contains DI Package
04046963456788
Package Discontinue Date
October 20, 2017
Package Status
Not in Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 277 |
| U | Unclassified | 2 |