Catalog Number

88-8534

Brand Name

V. Mueller

Version/Model Number

88-8534

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 18, 2019

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

K925079

Product Code

HET

Product Code Name

LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Public Device Record Key

767ddea9-15fd-4a05-bebd-28293a1c8b5b

Public Version Date

March 24, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-