Catalog Number

-

Brand Name

Scintillant

Version/Model Number

2658-01-0001

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

K071180,K071180

Product Code

FTD

Product Code Name

Lamp, Surgical

Public Device Record Key

dab4388c-8fe8-4964-a600-60055e083f9f

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

August 19, 2016

Package DI Number

20865082000119

Quantity per Package

5

Contains DI Package

10865082000112

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box