MicroFrance® - CURETTE MCO207-1-5 DIA 1.5MM FENESTRATED - INTEGRA MICROFRANCE

Duns Number:276593071

Device Description: CURETTE MCO207-1-5 DIA 1.5MM FENESTRATED

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More Product Details

Catalog Number

MCO207-1-5

Brand Name

MicroFrance®

Version/Model Number

MCO207-1-5

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)

Yes

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

JYG

Product Code Name

CURETTE, EAR

Device Record Status

Public Device Record Key

503f743f-068d-4905-95f3-91413adc8732

Public Version Date

April 21, 2021

Public Version Number

4

DI Record Publish Date

January 12, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRA MICROFRANCE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1433
2 A medical device with a moderate to high risk that requires special controls. 879