Catalog Number

-

Brand Name

FLUOBEAM LX

Version/Model Number

FBLX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190891

Product Code

QDG

Product Code Name

Parathyroid Autofluorescence Imaging Device

Public Device Record Key

3f34ea4a-36b6-4ab6-9ed4-b10cabf38265

Public Version Date

September 13, 2019

Public Version Number

1

DI Record Publish Date

September 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-