Henry Schein - Ultra Clean Powder - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: Ultra Clean Powder

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


More Product Details

Catalog Number

1022255

Brand Name

Henry Schein

Version/Model Number

1022255

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

For Single-Use

-

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

FLG

Product Code Name

Cleaner, ultrasonic, medical instrument

Device Record Status

Public Device Record Key

a85c05e8-127c-4c31-98f3-15cef2f343ab

Public Version Date

March 11, 2020

Public Version Number

1

DI Record Publish Date

March 03, 2020

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