Duns Number:803401454
Device Description: Unifine Ultra Pen Needle - 5mm x 31G
Catalog Number
-
Brand Name
Unifine Ultra
Version/Model Number
AN 4150
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K210399,K210399,K210399
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
0846625d-04f2-457e-b258-1377a918b07b
Public Version Date
March 21, 2022
Public Version Number
1
DI Record Publish Date
March 11, 2022
Package DI Number
00384704150033
Quantity per Package
12
Contains DI Package
00384704150019
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |