EN Snare® - Merit Medical Systems, Inc.

Duns Number:184763290

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More Product Details

Catalog Number

EN2007030/B

Brand Name

EN Snare®

Version/Model Number

00884450452479

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

K151497,K151497

Product Code Details

Product Code

MMX

Product Code Name

Device, percutaneous retrieval

Device Record Status

Public Device Record Key

e3a389cd-8cd8-4e9d-a5c4-5dd8063d5446

Public Version Date

July 08, 2021

Public Version Number

2

DI Record Publish Date

February 06, 2020

Additional Identifiers

Package DI Number

10884450452476

Quantity per Package

20

Contains DI Package

00884450452479

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