Medallion® - Merit Medical Systems, Inc.

Duns Number:184763290

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More Product Details

Catalog Number

MSS131-LB/B

Brand Name

Medallion®

Version/Model Number

00884450610190

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

1f76d713-c5a6-467c-80ba-f0361c7e07b1

Public Version Date

October 13, 2022

Public Version Number

1

DI Record Publish Date

October 05, 2022

Additional Identifiers

Package DI Number

10884450610197

Quantity per Package

25

Contains DI Package

00884450610190

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