Catalog Number

MOR-1515-6

Brand Name

LiNA Xcise™, Laparoscopic Morcellator

Version/Model Number

MOR-1515-6

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

5db2d929-a0f4-4fd6-ae2a-70a7bc1d4fc1

Public Version Date

December 03, 2020

Public Version Number

3

DI Record Publish Date

September 15, 2016

Package DI Number

05708265004713

Quantity per Package

6

Contains DI Package

05708265004706

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box