Duns Number:422528088
Device Description: 90 pcs sterile, single use droplet pen needles per box, intended to be used with a pen inj 90 pcs sterile, single use droplet pen needles per box, intended to be used with a pen injector device for the subcutaneous injection of drugs.
Catalog Number
7874
Brand Name
droplet ® pen needles
Version/Model Number
29G x 12mm
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
02608f12-b6ea-47b1-b3c6-3d46b69e2eed
Public Version Date
July 24, 2019
Public Version Number
1
DI Record Publish Date
July 16, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |