Duns Number:069590113
Device Description: SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder 21G*1 1/4
Catalog Number
-
Brand Name
SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder
Version/Model Number
SMSNH21125
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
5477a47f-ec99-4dba-92ee-a966cd15cc96
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
October 16, 2019
Package DI Number
20818392014956
Quantity per Package
8
Contains DI Package
10818392014959
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 |