Catalog Number

XSC01

Brand Name

X-SCREEN

Version/Model Number

X-SCREEN

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"

-

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

K051506,K051506

Product Code

FCG

Product Code Name

Biopsy Needle

Public Device Record Key

e1efc02b-55e2-4c81-882a-fcc8e3079273

Public Version Date

October 10, 2019

Public Version Number

1

DI Record Publish Date

October 02, 2019

Package DI Number

18033959220426

Quantity per Package

25

Contains DI Package

08033959220429

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-