SHEATH INTRO KIT 6FR L5 MULT=5/50 - Catheter 6FR, Percutaneous Sheath Introducer with - ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Duns Number:595138793

Device Description: Catheter 6FR, Percutaneous Sheath Introducer with Sideport Haemostasiss Valve OD 2.76mm x Catheter 6FR, Percutaneous Sheath Introducer with Sideport Haemostasiss Valve OD 2.76mm x ID 1.90mm x 10cm and Dilator, guidewire 0.9x450mm, introducers 1.7x70mm 1.4x70mm, contamination shield, stopcock, syringe and scalpel.

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


More Product Details

Catalog Number

680128

Brand Name

SHEATH INTRO KIT 6FR L5 MULT=5/50

Version/Model Number

680128

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)

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

DYB

Product Code Name

Introducer, Catheter

Device Record Status

Public Device Record Key

467719b5-59dd-4f66-bfaf-18ef91f8647b

Public Version Date

March 05, 2020

Public Version Number

3

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

50886333601283

Quantity per Package

50

Contains DI Package

00886333601288

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

tyvek tray

"ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 392