Catalog Number

001-541

Brand Name

X-Series Size 1 Horizontal Bitewing YELLOW Bite Block 3-pack

Version/Model Number

001-541

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EGZ

Product Code Name

Holder, Film, X-Ray

Public Device Record Key

fa0601a3-2d17-448b-8eb0-eb0f3b143422

Public Version Date

January 08, 2021

Public Version Number

1

DI Record Publish Date

December 31, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-