Catalog Number

200549

Brand Name

iCAP Imaging Cap

Version/Model Number

IC-100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2017

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

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

aac518e9-bf29-4a60-bef4-27c2721d9fc8

Public Version Date

December 08, 2020

Public Version Number

4

DI Record Publish Date

September 19, 2016

Package DI Number

893872001462

Quantity per Package

15

Contains DI Package

00893872001028

Package Discontinue Date

November 30, 2017

Package Status

Not in Commercial Distribution

Package Type

Multiple Unit Box