Catalog Number

LAFOG-FT

Brand Name

V. Mueller

Version/Model Number

LAFOG-FT

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"

Yes

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

OCT

Product Code Name

Anti fog solution and accessories, endoscopy

Public Device Record Key

40cd392c-b027-4133-bae5-6051fe3017a8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 09, 2017

Package DI Number

20885403231640

Quantity per Package

20

Contains DI Package

10885403231643

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box