Catalog Number

OP-SCI-3

Brand Name

LiNA OperaScope™ Scissors

Version/Model Number

OP-SCI-3

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

22ee4d0d-732e-43bc-9f87-c33a7223c8a1

Public Version Date

July 08, 2019

Public Version Number

1

DI Record Publish Date

June 28, 2019

Package DI Number

05708265011506

Quantity per Package

3

Contains DI Package

05708265011490

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-