Duns Number:926603486
Device Description: the needle is a hollow needle commonly used with a syringe to inject substances into the b the needle is a hollow needle commonly used with a syringe to inject substances into the body or extract fluids from it.
Catalog Number
DU2553
Brand Name
Hypodermic Needle 18Gx1"
Version/Model Number
1
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
6d5519dc-9505-4b68-965b-3489d1d395a8
Public Version Date
August 14, 2020
Public Version Number
1
DI Record Publish Date
August 06, 2020
Package DI Number
10850014433366
Quantity per Package
100
Contains DI Package
00850014433369
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bx
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |