Catalog Number

Mimics Enlight Medical

Brand Name

Mimics Enlight

Version/Model Number

Mimics Enlight Medical

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K190874

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

16750a35-4bf6-4d74-ac42-c94c1bcb7751

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

August 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-