Duns Number:803401454
Device Description: Unifine Safe Control Pen Needles 5mm x 30G Sample Bags
Catalog Number
-
Brand Name
Unifine Safe Control
Version/Model Number
AN 0955SB2
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
K173881,K173881,K173881
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
2963bc3d-9397-491c-8b71-7edc56dcf5ef
Public Version Date
August 05, 2021
Public Version Number
2
DI Record Publish Date
October 02, 2020
Package DI Number
00384700955236
Quantity per Package
500
Contains DI Package
00384700955212
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 |