Duns Number:803401454
Device Description: 5mm x 30G pen needle Sample Bags
Catalog Number
-
Brand Name
Unifine Pentips Plus RapidFlow
Version/Model Number
AN 0855SB2
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)
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
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
871e7f1b-377a-4379-b28b-eb7a4fae2f03
Public Version Date
July 22, 2021
Public Version Number
2
DI Record Publish Date
February 26, 2021
Package DI Number
00384700855239
Quantity per Package
200
Contains DI Package
00384700855215
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 |