Catalog Number

300.16SC

Brand Name

V. Mueller

Version/Model Number

300.16SC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 22, 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

K974382,K974382

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

418dc448-767d-4f55-b5d3-3302002273ba

Public Version Date

February 19, 2019

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-