Catalog Number

INTEGRESCAN-RG

Brand Name

Ellex

Version/Model Number

INTEGRESCAN-RG

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

K142398

Product Code

HQF

Product Code Name

Laser, Ophthalmic

Public Device Record Key

cda69e74-fbbb-4f79-801b-0d684ce6ef3c

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

March 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-