Malleable Suction Tube - Malleable Suction Tube, 9Fr, Cvd, Down - MIZUHO CORPORATION

Duns Number:690677802

Device Description: Malleable Suction Tube, 9Fr, Cvd, Down

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More Product Details

Catalog Number

07-794-76

Brand Name

Malleable Suction Tube

Version/Model Number

07-794-76

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

JOL

Product Code Name

Catheter And Tip, Suction

Device Record Status

Public Device Record Key

55a52e80-4f22-469e-8d80-fb8fe0559e77

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

May 25, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MIZUHO CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 696
2 A medical device with a moderate to high risk that requires special controls. 566