Catalog Number

-

Brand Name

Scintillant

Version/Model Number

2658-01-0004

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FTD

Product Code Name

Lamp, Surgical

Public Device Record Key

987aed3e-7eea-44f6-a48b-b1bd99dbffa4

Public Version Date

May 10, 2021

Public Version Number

6

DI Record Publish Date

August 19, 2016

Package DI Number

20865082000133

Quantity per Package

5

Contains DI Package

10865082000136

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box