Catalog Number

-

Brand Name

PROBE ARM SET B

Version/Model Number

MAJ-1153

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 09, 2022

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K002749

Product Code

FDA

Product Code Name

Enteroscope And Accessories

Public Device Record Key

bbbbfe2e-5ca0-474e-9eb6-9512f7e9e478

Public Version Date

August 10, 2022

Public Version Number

2

DI Record Publish Date

December 17, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-