MedSource Yankaeur TipTube Only - MedSource Yankaeur TipTube Only - MEDSOURCE INTERNATIONAL LLC

Duns Number:041674552

Device Description: MedSource Yankaeur TipTube Only

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More Product Details

Catalog Number

-

Brand Name

MedSource Yankaeur TipTube Only

Version/Model Number

MS-YK30

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

GCX

Product Code Name

Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Device Record Status

Public Device Record Key

c9c8264f-dec7-4459-acf1-f585fcd59c89

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 29, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDSOURCE INTERNATIONAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 498
2 A medical device with a moderate to high risk that requires special controls. 90