Catalog Number

0605-60

Brand Name

CT/MR Split-Ring Appl Set, 32mm, 60ø

Version/Model Number

0605-60

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

-

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

K063382

Product Code

JAQ

Product Code Name

System, Applicator, Radionuclide, Remote-Controlled

Public Device Record Key

9b1a1c64-cb98-4e51-8794-a2943c1a8a6d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-