MicroFrance® - PLATE MCL35 FOR MCL76 BOUCHAYER - INTEGRA MICROFRANCE

Duns Number:276593071

Device Description: PLATE MCL35 FOR MCL76 BOUCHAYER

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More Product Details

Catalog Number

MCL35

Brand Name

MicroFrance®

Version/Model Number

MCL35

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

CCW

Product Code Name

LARYNGOSCOPE, RIGID

Device Record Status

Public Device Record Key

6e1f6c1a-2036-4da4-8ed7-9e1344f63adc

Public Version Date

June 10, 2022

Public Version Number

3

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