MicroFrance® - INJECTION NEEDLE MCL55T5 6PK CASIANO - INTEGRA MICROFRANCE

Duns Number:276593071

Device Description: INJECTION NEEDLE MCL55T5 6PK CASIANO

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More Product Details

Catalog Number

MCL55T5

Brand Name

MicroFrance®

Version/Model Number

MCL55T5

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

Yes

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

GDM

Product Code Name

NEEDLE, ASPIRATION AND INJECTION, REUSABLE

Device Record Status

Public Device Record Key

f09c069b-753e-491f-91bf-c0ec4aaecb63

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 10, 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