Catalog Number

89-8502

Brand Name

V. Mueller

Version/Model Number

89-8502

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

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

-

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

257eddc3-a506-451a-92a9-661af46af045

Public Version Date

February 19, 2019

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

70885403156801

Quantity per Package

10

Contains DI Package

20885403156806

Package Discontinue Date

May 22, 2018

Package Status

Not in Commercial Distribution

Package Type

Case