Catalog Number

LA8000

Brand Name

V. Mueller

Version/Model Number

LA8000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 01, 2017

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

HET

Product Code Name

LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Public Device Record Key

647eae13-efc0-4065-8522-056ec611b84f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 09, 2017

Package DI Number

20885403067584

Quantity per Package

10

Contains DI Package

10885403067587

Package Discontinue Date

April 21, 2016

Package Status

Not in Commercial Distribution

Package Type

Box