Flex-Neck® - Merit Medical Systems, Inc.

Duns Number:184763290

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More Product Details

Catalog Number

CF-5442/A

Brand Name

Flex-Neck®

Version/Model Number

00884450170311

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

DRE

Product Code Name

DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Device Record Status

Public Device Record Key

c27df053-67fa-4cae-a716-ab4416a853b3

Public Version Date

October 11, 2021

Public Version Number

4

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

10884450170318

Quantity per Package

30

Contains DI Package

00884450170311

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