Catalog Number

MIS-100

Brand Name

LUMIN

Version/Model Number

Uterine Manipulator

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

K943448,K943448

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Public Device Record Key

e0124de3-4fb3-48f7-9a6f-c746c18e98b8

Public Version Date

December 24, 2019

Public Version Number

1

DI Record Publish Date

December 16, 2019

Package DI Number

H671MIS1001

Quantity per Package

10

Contains DI Package

H671MIS1000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box