Catalog Number

-

Brand Name

AED

Version/Model Number

ML3500

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 18, 2018

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

K993688

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

4da9aece-2cbc-49da-a77c-44e6a3204c40

Public Version Date

December 19, 2018

Public Version Number

4

DI Record Publish Date

December 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-