Duns Number:422528088
Device Description: 100 pcs sterile single use DropSafe pen needles per box, intended for use with pen injecto 100 pcs sterile single use DropSafe pen needles per box, intended for use with pen injector devices for the injection of drugs.
Catalog Number
8161
Brand Name
DropSafe, safety pen needles
Version/Model Number
31G x 5mm
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)
-
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
5ee4858f-d199-4263-b3ac-2dc07b4fa0c6
Public Version Date
October 26, 2021
Public Version Number
1
DI Record Publish Date
October 18, 2021
Package DI Number
15907996098580
Quantity per Package
20
Contains DI Package
05907996098583
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipper box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |