Duns Number:151810868
Device Description: Walgreens TRUEplus Pen Needles 5Bevel - 32G 4mm - 50ct box
Catalog Number
S6001A32-50
Brand Name
TRUEplus
Version/Model Number
TRUEplus Pen Needles 5Bevel - 32G 4mm
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
K180720,K180720,K180720
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
17836de8-e78a-4be7-affc-80cfdea7bcea
Public Version Date
August 03, 2022
Public Version Number
1
DI Record Publish Date
July 26, 2022
Package DI Number
10311917136346
Quantity per Package
60
Contains DI Package
00311917136349
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 | 25 |
2 | A medical device with a moderate to high risk that requires special controls. | 22 |