Catalog Number

GIs-44

Brand Name

SPOT Endosopic Marker

Version/Model Number

GIS-44

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

44302e8f-39a2-4023-a425-a3244f44f97d

Public Version Date

February 17, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

00893029002441

Quantity per Package

10

Contains DI Package

00893029002069

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10 Count Canister