Integra® MicroFrance® - INJECTION NEEDLE MCL55-1 240MM BAYONET - INTEGRA MICROFRANCE

Duns Number:276593071

Device Description: INJECTION NEEDLE MCL55-1 240MM BAYONET

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More Product Details

Catalog Number

MCL55-1

Brand Name

Integra® MicroFrance®

Version/Model Number

MCL55-1

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

K993655

Product Code Details

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Record Status

Public Device Record Key

e0fa4704-d6fb-47f2-8b08-c13c5a634b02

Public Version Date

October 04, 2022

Public Version Number

4

DI Record Publish Date

September 20, 2016

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