Duns Number:012177531
Device Description: NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for us NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection.
Catalog Number
185550
Brand Name
NovoFine® Plus 32G
Version/Model Number
185550
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
K133738,K202005,K133738,K202005,K133738,K202005
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
680fd340-3034-4874-a52c-ff22af41d6c1
Public Version Date
July 21, 2021
Public Version Number
4
DI Record Publish Date
September 17, 2016
Package DI Number
30301691855506
Quantity per Package
60
Contains DI Package
00301691855505
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 |