Catalog Number

105401

Brand Name

Evotech

Version/Model Number

105401

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K082392,K140977

Product Code

FEB

Product Code Name

Accessories, cleaning, for endoscope

Public Device Record Key

c57e8e52-1d4a-4c36-ad2a-105056861737

Public Version Date

December 11, 2020

Public Version Number

3

DI Record Publish Date

May 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-