Duns Number:002397347
Device Description: 1 mL TB 25 Ga. x 5/8 in. Detachable Needle
Catalog Number
9161422-02
Brand Name
Omnifix™
Version/Model Number
9161422-02
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 04, 2020
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
512d15ad-40b5-4b8c-b64d-7ca6f62c4d40
Public Version Date
March 19, 2021
Public Version Number
6
DI Record Publish Date
September 23, 2016
Package DI Number
04046963452414
Quantity per Package
16
Contains DI Package
04046963452407
Package Discontinue Date
April 04, 2020
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 |