Duns Number:217266915
Device Description: Non-sterile reusable autoinjector device, with an external indicator, for the injection of Non-sterile reusable autoinjector device, with an external indicator, for the injection of FDA-approved drugs from fixed needle syringes
Catalog Number
AJ1310
Brand Name
Autoject EI
Version/Model Number
AJ1310
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
-
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
K945660,K945660
Product Code
KZH
Product Code Name
Introducer, Syringe Needle
Public Device Record Key
eb1114d8-ac6a-4e80-87cd-b2715e244a4d
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 19, 2016
Package DI Number
00384701310034
Quantity per Package
50
Contains DI Package
00384701310010
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 | 1 |