Merit Medical® - Merit Medical Systems, Inc.

Duns Number:603160040

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More Product Details

Catalog Number

K12T-12307

Brand Name

Merit Medical®

Version/Model Number

00884450691182

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

OEQ

Product Code Name

Angiography/angioplasty kit

Device Record Status

Public Device Record Key

bddd8210-a012-4b98-b835-be350a16fd1c

Public Version Date

September 23, 2022

Public Version Number

1

DI Record Publish Date

September 15, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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