Catalog Number

-

Brand Name

The Fast Find Grid

Version/Model Number

EG6500

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

K950980,K950980,K950980

Product Code

KPR

Product Code Name

System, X-Ray, Stationary

Public Device Record Key

3f688243-53f3-4387-bdaf-b71cb69ee9b8

Public Version Date

July 10, 2018

Public Version Number

4

DI Record Publish Date

March 22, 2017

Package DI Number

00086804000033

Quantity per Package

25

Contains DI Package

00868040000301

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Sleeve