Catalog Number

-

Brand Name

Surgimedics®

Version/Model Number

905054

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FCZ

Product Code Name

Tube, Smoke Removal, Endoscopic

Public Device Record Key

6749f035-729e-4855-aa7a-4d4e4efe7b3a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

10814716020675

Quantity per Package

24

Contains DI Package

00814716020678

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-