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 of drugs, including insulin, GLP-1 analogs, and somatropin.
Catalog Number
185651
Brand Name
NovoFine® Plus 32G
Version/Model Number
185651
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 06, 2017
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,K133738,K133738
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
328afccf-58f2-40b3-ba20-518a0b1fcb80
Public Version Date
July 20, 2021
Public Version Number
4
DI Record Publish Date
December 06, 2017
Package DI Number
30301691856510
Quantity per Package
288
Contains DI Package
00301691856519
Package Discontinue Date
December 06, 2017
Package Status
Not 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 |