Catalog Number

GIS-45

Brand Name

Spot Ex Endoscopic Tattoo

Version/Model Number

GIS-45

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

Yes

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

NBG

Product Code Name

Marker,Colon

Public Device Record Key

7582ee7e-4b44-4cb3-a0b5-656f3879e3d6

Public Version Date

February 17, 2021

Public Version Number

3

DI Record Publish Date

December 26, 2017

Package DI Number

10893029002103

Quantity per Package

10

Contains DI Package

00893029002106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10 Count Box