Catalog Number

0612-16

Brand Name

CT/MR Fletcher (FSD) Mini Ovoid Pair 1.5cm (2pcs)

Version/Model Number

0612-16

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

K063381

Product Code

JAQ

Product Code Name

System, Applicator, Radionuclide, Remote-Controlled

Public Device Record Key

77dbc167-28c5-4fce-ba88-426ed9b64922

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-