Catalog Number

AG-08

Brand Name

AccuGel

Version/Model Number

AG-08

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K012522,K012522,K012522

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

ec493459-fe0a-40c6-87da-51479e7f96ef

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

February 13, 2017

Package DI Number

20851491007368

Quantity per Package

48

Contains DI Package

00851491007364

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS