Kensington™ - Merit Medical Systems, Inc.

Duns Number:184763290

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

KBC1110/B

Brand Name

Kensington™

Version/Model Number

00884450411834

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

GAA

Product Code Name

NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Device Record Status

Public Device Record Key

56d2b808-0ed4-4f13-b062-4f64d77ae5c7

Public Version Date

January 10, 2020

Public Version Number

1

DI Record Publish Date

January 02, 2020

Additional Identifiers

Package DI Number

10884450411831

Quantity per Package

14

Contains DI Package

00884450411834

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