Catalog Number

-

Brand Name

MR Catheter

Version/Model Number

4013-12

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K201466,K201466,K201466

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

65662953-3e5d-49de-9884-65547665315b

Public Version Date

October 10, 2022

Public Version Number

2

DI Record Publish Date

November 08, 2021

Package DI Number

37340007000592

Quantity per Package

5

Contains DI Package

17340007000598

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-