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
112215
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
1d386535-a23a-41c9-ade8-001e6a00000d
Public Version Date
October 23, 2019
Public Version Number
6
DI Record Publish Date
September 16, 2016
Package DI Number
10818392015123
Quantity per Package
100
Contains DI Package
00818392015126
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 161 |