CFM Technologies - Cerumen Management Set with reusable and - C F M TECHNOLOGIES INC

Duns Number:040748944

Device Description: Cerumen Management Set with reusable and single-use curettes.

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More Product Details

Catalog Number

CM2-BL

Brand Name

CFM Technologies

Version/Model Number

CM2 Blue

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"

-

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 Details

Product Code

JYG

Product Code Name

Curette, Ear

Device Record Status

Public Device Record Key

5d179429-3c5a-4740-b79f-521ffe042b69

Public Version Date

April 21, 2021

Public Version Number

2

DI Record Publish Date

January 06, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"C F M TECHNOLOGIES INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 26