Catalog Number

-

Brand Name

TUBESET, LENS CLEANER STANDARD InstaClear TUBESET, LENS CLEANER

Version/Model Number

LCTS100S

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

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

K152531,K152531

Product Code

EOB

Product Code Name

NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Public Device Record Key

c97fe95c-d083-4db0-bf96-000d548fe9f8

Public Version Date

April 09, 2019

Public Version Number

4

DI Record Publish Date

October 05, 2016

Package DI Number

00821925039889

Quantity per Package

5

Contains DI Package

00821925040052

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-