Catalog Number

OP-GRA-6

Brand Name

LiNA OperaScope™ Rat Tooth Alligator Grasper

Version/Model Number

OP-GRA-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

NWW

Product Code Name

Hysteroscope Accessories

Public Device Record Key

c15e7c14-95cf-4e72-a12e-993ffd761695

Public Version Date

August 21, 2019

Public Version Number

2

DI Record Publish Date

April 11, 2018

Package DI Number

05708265010226

Quantity per Package

6

Contains DI Package

05708265010219

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-