Duns Number:803401454
Device Description: Unifine Pentips pen needles - 8mm x 31G
Catalog Number
-
Brand Name
Unifine Pentips
Version/Model Number
AN 3530
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
K152339,K152339,K152339,K152339
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
e8a3dd2f-a881-400d-8679-588eb9b0b22d
Public Version Date
March 17, 2022
Public Version Number
4
DI Record Publish Date
September 19, 2016
Package DI Number
00384703530027
Quantity per Package
10
Contains DI Package
00384703530010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Sleeve
| 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 |