ARROW - Percutaneous Cavity Drainage Catheterization Kit - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Percutaneous Cavity Drainage Catheterization Kit Seldinger Insertion Technique

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


More Product Details

Catalog Number

AK-01600

Brand Name

ARROW

Version/Model Number

IPN036836

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K895516,K895516

Product Code Details

Product Code

GBX

Product Code Name

CATHETER, IRRIGATION

Device Record Status

Public Device Record Key

2034465d-9e31-4c2d-bbf8-e3ad8065bed8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 28, 2017

Additional Identifiers

Package DI Number

30801902120152

Quantity per Package

5

Contains DI Package

20801902120155

Package Discontinue Date

February 22, 2018

Package Status

Not in Commercial Distribution

Package Type

Case

"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