Catalog Number

5864

Brand Name

RUSCH

Version/Model Number

IPN915593

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

b3c7a2b3-a02a-4cd8-982f-b1d97089e7d7

Public Version Date

May 24, 2021

Public Version Number

1

DI Record Publish Date

May 14, 2021

Package DI Number

54026704712736

Quantity per Package

56

Contains DI Package

14026704712738

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton