Catalog Number

900492-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

55c9fc76-2c7d-4c86-8686-3c4a5c7431c4

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

August 01, 2016

Package DI Number

08033860021825

Quantity per Package

5

Contains DI Package

08033860021818

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-