Catalog Number

-

Brand Name

AED

Version/Model Number

32-4106

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KQT

Product Code Name

EVACUATOR, GASTRO-UROLOGY

Public Device Record Key

858b7ef4-8d4b-47d3-b097-ae63b0f2136e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-