Duns Number:438746708
Catalog Number
900490-US
Brand Name
SOMATEX
Version/Model Number
SOMACORE VERIFY S
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
K130616,K130616
Product Code
FCG
Product Code Name
Biopsy Needle
Public Device Record Key
cde028d6-04bf-44e9-8fdf-d1bbb21713c5
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
August 01, 2016
Package DI Number
08033860021801
Quantity per Package
5
Contains DI Package
08033860021795
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 41 |
2 | A medical device with a moderate to high risk that requires special controls. | 37 |