Catalog Number

5138

Brand Name

NA

Version/Model Number

NA

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

K982462,K982462

Product Code

FFS

Product Code Name

Image, Illumination, Fiberoptic, For Endoscope

Public Device Record Key

94037735-4a20-4071-8d93-38355b6ac2e0

Public Version Date

May 07, 2019

Public Version Number

4

DI Record Publish Date

January 17, 2018

Package DI Number

30818255010474

Quantity per Package

5

Contains DI Package

10818255010470

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton