Catalog Number

600001

Brand Name

Fast Find Grid: Disposable CT Biopsy Grid

Version/Model Number

600001

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

-

Product Code

KPR

Product Code Name

System, X-Ray, Stationary

Public Device Record Key

3debf30c-31ad-4b8f-9923-f3cb77eaf452

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2016

Package DI Number

30815112020218

Quantity per Package

25

Contains DI Package

10815112020214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Sleeve