Duns Number:012177531
Device Description: NovoTwist® 32G is a single use disposable injection needle intended for use with pen injec
Catalog Number
185389
Brand Name
NovoTwist® 32G
Version/Model Number
185389
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K093109,K093109,K093109
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
83ddd180-00ba-4118-b586-1a8fe45909bd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 17, 2016
Package DI Number
30301691853892
Quantity per Package
60
Contains DI Package
00301691853891
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |