Catalog Number

ACC-GFU-100

Brand Name

Gas Filter Unit

Version/Model Number

ACC-GFU-100

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

K073409,K073409

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

678ad991-8ed6-406b-b5a6-ac9bbb631c26

Public Version Date

September 22, 2020

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

00894338002733

Quantity per Package

10

Contains DI Package

10894338002693

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box