Catalog Number

MOR2-1515-6

Brand Name

LiNA Xcise™, Laparoscopic Morcellator

Version/Model Number

MOR2-1515-6

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

6223b84c-2ca9-47d6-a8d7-9860405981a7

Public Version Date

December 10, 2020

Public Version Number

1

DI Record Publish Date

December 02, 2020

Package DI Number

05708265012534

Quantity per Package

6

Contains DI Package

05708265012527

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box