Catalog Number

PBX-M1-N25

Brand Name

Paradigm BX

Version/Model Number

M1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

EKS

Product Code Name

File, Pulp Canal, Endodontic

Public Device Record Key

6be7489b-3a47-4dbd-9000-ae15cb19ed1c

Public Version Date

May 29, 2020

Public Version Number

1

DI Record Publish Date

May 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-