Catalog Number

ESU Pencil non-switch w/blade

Brand Name

Galemed

Version/Model Number

8581G

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CCW

Product Code Name

Laryngoscope, Rigid

Public Device Record Key

b195ab83-ae3a-419c-beb1-9e29a132285a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 15, 2015

Package DI Number

44710810089440

Quantity per Package

8

Contains DI Package

24710810089446

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton