Catalog Number

ED1

Brand Name

ArcScan Insight 100

Version/Model Number

EyeSeal Disposable

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"

Yes

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

1bc953aa-4784-4850-8668-69c9819ba97b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 04, 2016

Package DI Number

B017ED113

Quantity per Package

10

Contains DI Package

B017ED102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box of 10