MedSource Sharps Dart 24/case - Sharps Dart 24/case - MEDSOURCE INTERNATIONAL LLC

Duns Number:041674552

Device Description: Sharps Dart 24/case

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More Product Details

Catalog Number

-

Brand Name

MedSource Sharps Dart 24/case

Version/Model Number

MS-64250

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K150333,K150333,K150333

Product Code Details

Product Code

MMK

Product Code Name

Container, Sharps

Device Record Status

Public Device Record Key

b6aa29aa-d14e-4407-b407-a4ac93a154f9

Public Version Date

October 15, 2021

Public Version Number

4

DI Record Publish Date

July 14, 2016

Additional Identifiers

Package DI Number

10816703021399

Quantity per Package

24

Contains DI Package

00816703021392

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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