Channels - Channels Flex 25mm 50.04 - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: Channels Flex 25mm 50.04

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

2020563

Brand Name

Channels

Version/Model Number

2020563

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

Yes

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 Details

Product Code

EKS

Product Code Name

FILE, PULP CANAL, ENDODONTIC

Device Record Status

Public Device Record Key

3a934212-c2f2-476b-8f32-28899618776f

Public Version Date

July 13, 2022

Public Version Number

1

DI Record Publish Date

July 05, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HENRY SCHEIN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3829
2 A medical device with a moderate to high risk that requires special controls. 2579
3 A medical device with high risk that requires premarket approval 1
U Unclassified 34