Catalog Number

4001GF

Brand Name

GRAFCO

Version/Model Number

4001GF

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K955246,K955246

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

6ec5da1c-b3ab-4531-a1af-86d07ef199c4

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 01, 2020

Package DI Number

M3684001GF2

Quantity per Package

12

Contains DI Package

M3684001GF1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box