Duns Number:069590113
Device Description: SOL-M™ Multi-Sample Needle 18G*1 1/2”
Catalog Number
-
Brand Name
SOL-M™ Multi-Sample Needle
Version/Model Number
110201020009
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
0e2dae33-5d8b-4188-b3e6-be7de07e7eec
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
July 03, 2018
Package DI Number
10818392015376
Quantity per Package
100
Contains DI Package
00818392015379
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 |