Catalog Number

ICM-000-0602

Brand Name

Smoke Evacuator Wand

Version/Model Number

ICM-000-0602

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"

Yes

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

FYD

Product Code Name

Apparatus, Exhaust, Surgical

Public Device Record Key

3479ee18-8388-4345-81be-267990151d29

Public Version Date

November 12, 2020

Public Version Number

1

DI Record Publish Date

November 04, 2020

Package DI Number

00817688022961

Quantity per Package

15

Contains DI Package

00817688022954

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-