Duns Number:002397347
Device Description: Injekt™ 1 mL LS with 25 Ga. x 5/8 in. Needle
Catalog Number
9166033V-02
Brand Name
INJEKT™
Version/Model Number
9166033V-02
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
8451f8f0-f52f-4876-9198-fbad6f9b7e1c
Public Version Date
August 09, 2022
Public Version Number
9
DI Record Publish Date
January 18, 2017
Package DI Number
04046964001949
Quantity per Package
18
Contains DI Package
04046964001932
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 277 |
| U | Unclassified | 2 |