Catalog Number

-

Brand Name

BONASCAN HEAVY

Version/Model Number

Fast Set, 50ml

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

-

FDA Premarket Submission

-

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

2616ff6e-1d01-4bc8-a2d8-717d5c9d2c2a

Public Version Date

July 27, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

05206569430226

Quantity per Package

4

Contains DI Package

05206569000771

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box