Catalog Number

EX2620-3D-AE

Brand Name

NA

Version/Model Number

EX2620-3D, PU008

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 30, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KQM

Product Code Name

Camera, Surgical And Accessories

Public Device Record Key

e8a0d027-1e27-4d6b-bd46-4167030f2377

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

September 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-