Duns Number:069590113
Device Description: Sterile hypodermic needles intended to inject fluids into, or withdraw fluids from, parts Sterile hypodermic needles intended to inject fluids into, or withdraw fluids from, parts of the body below the suface of the skin.
Catalog Number
-
Brand Name
SOL-M™ Hypodermic Needle
Version/Model Number
112705
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
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
98e603b7-3c48-471b-b58a-30a0a662cbd9
Public Version Date
October 23, 2019
Public Version Number
6
DI Record Publish Date
September 16, 2016
Package DI Number
20818392015182
Quantity per Package
10
Contains DI Package
10818392015185
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 161 |