Duns Number:002397347
Device Description: OMNICAN FINE PEN NEEDLE 31GX8MM W CAP US
Catalog Number
931G08S-02
Brand Name
Omnican®
Version/Model Number
931G08S-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"
-
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
K173803,K173803,K173803
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
d63682f1-7a74-45a8-b8b9-b9e46459d115
Public Version Date
August 30, 2021
Public Version Number
4
DI Record Publish Date
September 22, 2018
Package DI Number
04046955064373
Quantity per Package
10
Contains DI Package
04046955064366
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 |