Catalog Number

29003

Brand Name

HUDSON RCI

Version/Model Number

IPN044136

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

Yes

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

MNK

Product Code Name

Endoscopic bite block

Public Device Record Key

5807d18d-da38-4eb8-b2ab-264261944234

Public Version Date

October 16, 2018

Public Version Number

1

DI Record Publish Date

September 15, 2018

Package DI Number

24026704582239

Quantity per Package

20

Contains DI Package

04026704582235

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box