Duns Number:002397347
Device Description: 10 mL LL 21 Ga. x 1 in.
Catalog Number
4611035-02
Brand Name
Omnifix™
Version/Model Number
4611035-02
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 29, 2019
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
112590d3-0bb3-4ebd-ae61-1ea20daef4e0
Public Version Date
March 19, 2021
Public Version Number
7
DI Record Publish Date
September 23, 2016
Package DI Number
04046963452209
Quantity per Package
9
Contains DI Package
04046963452193
Package Discontinue Date
June 29, 2019
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 |