Catalog Number

F87629

Brand Name

ACTEON

Version/Model Number

CS1 M+ TIP N STER

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JDX

Product Code Name

Instrument, Surgical, Sonic And Accessory/Attachment

Public Device Record Key

9b3bb99f-8f31-4a07-8e42-ba7adc993d0f

Public Version Date

April 25, 2022

Public Version Number

1

DI Record Publish Date

April 15, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-