Catalog Number

LK158PE

Brand Name

Aligned Medical Solutions

Version/Model Number

LK158PE

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

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

OJK

Product Code Name

Eye tray

Public Device Record Key

5e7c2de4-3045-4631-8e98-ce5e55c9ff4e

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

November 14, 2018

Package DI Number

B098LK158PE1

Quantity per Package

10

Contains DI Package

B098LK158PE0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case