Catalog Number

F1012

Brand Name

OptoWire

Version/Model Number

Deux

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

K152991,K152991,K152991

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

f34ff046-c57c-4b3b-b9b8-edc6d3dae0d9

Public Version Date

October 27, 2020

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

07540184510122

Quantity per Package

5

Contains DI Package

07540184110124

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box