ARROW - EZ-Stabilizer - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: EZ-Stabilizer

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


More Product Details

Catalog Number

9066-VC-005

Brand Name

ARROW

Version/Model Number

IPN033748

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

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

KMK

Product Code Name

DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Device Record Status

Public Device Record Key

6d0274bc-be06-42d5-ab38-2e2b670dff4d

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

June 18, 2020

Additional Identifiers

Package DI Number

20816000012554

Quantity per Package

5

Contains DI Package

10816000012557

Package Discontinue Date

February 02, 2022

Package Status

Not in Commercial Distribution

Package Type

Box

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26