Catalog Number

100412

Brand Name

Pediatric Bite Block

Version/Model Number

100412

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 25, 2022

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)

-

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

c954cd39-972f-419a-a3be-608d3cb9abef

Public Version Date

May 26, 2022

Public Version Number

4

DI Record Publish Date

March 19, 2021

Package DI Number

10677964060691

Quantity per Package

50

Contains DI Package

00677964060694

Package Discontinue Date

May 25, 2022

Package Status

Not in Commercial Distribution

Package Type

Box