Duns Number:088514898
Device Description: Needles for one.click® auto-injector. Single packed, sterile. For single use only. Non-pyr Needles for one.click® auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.
Catalog Number
16440EMD
Brand Name
one.click needle
Version/Model Number
U1244101
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
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
96c5eea0-07ac-4129-8a66-62de464e374c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 26, 2016
Package DI Number
04046963413804
Quantity per Package
12
Contains DI Package
04046963412791
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |