Catalog Number

20949201

Brand Name

ONE SHAPE APICAL

Version/Model Number

ONE SHAPE APICAL1 n030 6% L21 Classics sterile

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

45c42b1c-8974-4575-9b50-bc01c2d5ff85

Public Version Date

July 31, 2020

Public Version Number

1

DI Record Publish Date

July 23, 2020

Package DI Number

J015209492012

Quantity per Package

10

Contains DI Package

J015209492011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Grouping box