Catalog Number

TEM1240212EX

Brand Name

ALADDIN HW3.0

Version/Model Number

TEM1240212EX

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

K160327

Product Code

HJO

Product Code Name

Biomicroscope, Slit-Lamp, Ac-Powered

Public Device Record Key

c798a634-49ad-46c3-a673-0cb778225ccb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-