Duns Number:002397347
Device Description: OMNIFIX 1 ML LL FINE DOSAGE US
Catalog Number
9167006V-02
Brand Name
Omnifix®
Version/Model Number
9167006V-02
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)
Yes
Over the Counter (OTC)
-
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
d79f5013-ab50-46f0-8797-33b17a11c7d9
Public Version Date
November 26, 2020
Public Version Number
2
DI Record Publish Date
November 10, 2020
Package DI Number
04046955292011
Quantity per Package
24
Contains DI Package
04046955292004
Package Discontinue Date
-
Package Status
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 |