Catalog Number

512202/6

Brand Name

RUSCH

Version/Model Number

IPN048667

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

5db449ce-6ab4-49b5-affa-4648e28085b2

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 21, 2018

Package DI Number

44026704625862

Quantity per Package

66

Contains DI Package

14026704625861

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton