Catalog Number

CM1-BK

Brand Name

CFM Technologies

Version/Model Number

CM1 Black

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JYG

Product Code Name

Curette, Ear

Public Device Record Key

1eb3de9c-1caa-4175-8def-51b3c47c7b0b

Public Version Date

April 21, 2021

Public Version Number

2

DI Record Publish Date

January 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-