Duns Number:069590113
Device Description: SOL-M™ Multi-Sample Needle 21G*1 1/2"
Catalog Number
-
Brand Name
SOL-M™ Multi-Sample Needle
Version/Model Number
110201020005
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
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
18ac7ca5-a808-4ef3-a818-7279fef34fbf
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
July 03, 2018
Package DI Number
20818392015410
Quantity per Package
10
Contains DI Package
10818392015413
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 |