Catalog Number

1016767

Brand Name

Henry Schein

Version/Model Number

1016767

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FLG

Product Code Name

Cleaner, ultrasonic, medical instrument

Public Device Record Key

4ada57e4-37ac-42e4-a5e8-b1c93b594ebd

Public Version Date

June 26, 2020

Public Version Number

1

DI Record Publish Date

June 18, 2020

Package DI Number

H65810167671

Quantity per Package

6

Contains DI Package

H65810167670

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-