ARROW - 014 Arrow GPSCath, 5.5x20mm, 150cm - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: 014 Arrow GPSCath, 5.5x20mm, 150cm

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


More Product Details

Catalog Number

BTK-14-5H2150-A1

Brand Name

ARROW

Version/Model Number

IPN000431

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"

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

K142300,K142300,K142300

Product Code Details

Product Code

LIT

Product Code Name

Catheter, angioplasty, peripheral, transluminal

Device Record Status

Public Device Record Key

cc5745f2-51ee-4032-ab67-67a4235f93b8

Public Version Date

December 19, 2019

Public Version Number

5

DI Record Publish Date

April 20, 2017

Additional Identifiers

Package DI Number

30801902083877

Quantity per Package

1

Contains DI Package

00801902083876

Package Discontinue Date

December 18, 2019

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