Medallion® - Merit Medical Systems, Inc.

Duns Number:184763290

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More Product Details

Catalog Number

MSSF111/B

Brand Name

Medallion®

Version/Model Number

00884450610312

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMF

Product Code Name

Syringe, piston

Device Record Status

Public Device Record Key

97247840-9ad5-48d3-a5f1-89a37102b6a3

Public Version Date

May 06, 2022

Public Version Number

1

DI Record Publish Date

April 28, 2022

Additional Identifiers

Package DI Number

20884450610316

Quantity per Package

4

Contains DI Package

10884450610319

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MERIT MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 573
2 A medical device with a moderate to high risk that requires special controls. 8779