Duns Number:151810868
Device Description: 5-bevel V TRUEplus Pen Needle 32G/4mm - 100ct box
Catalog Number
S6H01A32-100V
Brand Name
TRUEplus
Version/Model Number
TRUEplus 5-bevel Pen Needle 32G/4mm - 100ct box
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 19, 2021
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
K180720,K180720,K180720
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
d50b0b80-a0b3-48f1-b2f2-eba7385ea1d8
Public Version Date
February 07, 2022
Public Version Number
2
DI Record Publish Date
September 22, 2021
Package DI Number
10021292014787
Quantity per Package
30
Contains DI Package
00021292014780
Package Discontinue Date
November 19, 2021
Package Status
Not 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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |