Catalog Number

4094

Brand Name

Satin™

Version/Model Number

4094

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

77fc135f-23af-4082-9778-e8fc17748d39

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

00634782548452

Quantity per Package

8

Contains DI Package

00634782048679

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master case