Duns Number:069590113
Device Description: SOL-CARE™ Safety Blood Collection Needle 21G*3/4*12inch (US)
Catalog Number
-
Brand Name
SOL-CARE™ Safety Blood Collection Needle
Version/Model Number
110201030031
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
76389644-50c2-49ab-8047-aebe3a0d5dcb
Public Version Date
July 23, 2020
Public Version Number
4
DI Record Publish Date
June 26, 2018
Package DI Number
20818392017261
Quantity per Package
4
Contains DI Package
10818392017264
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 |