Catalog Number

5845

Brand Name

RUSCH

Version/Model Number

IPN048454

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

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

3447cd89-b0c2-453e-91c2-6bb045caf0dd

Public Version Date

October 16, 2018

Public Version Number

1

DI Record Publish Date

September 15, 2018

Package DI Number

44026704628962

Quantity per Package

56

Contains DI Package

14026704628961

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton