Catalog Number

OP-TDK-6

Brand Name

LiNA OperaScope™ Tubing & Drape kit

Version/Model Number

OP-TDK-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

PXU

Product Code Name

Fluid Drainage Tray

Public Device Record Key

92c49a87-bed8-44a0-892b-99d7bc419061

Public Version Date

October 15, 2020

Public Version Number

2

DI Record Publish Date

September 04, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-