Catalog Number

F1032

Brand Name

OptoWire

Version/Model Number

III

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K191907,K191907,K191907

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

5207d88e-79a1-4ce1-82d6-15bc92615091

Public Version Date

October 27, 2020

Public Version Number

3

DI Record Publish Date

March 05, 2020

Package DI Number

07540184110322

Quantity per Package

5

Contains DI Package

07540184010325

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box