SHEATH INTRO POP KIT 9FR L5 MULT=5/50 - Kits Contents : Percutaneous Sheath Introducer - ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Duns Number:595138793

Device Description: Kits Contents : Percutaneous Sheath Introducer with Sideport Haemostasis Valve OD 3.70mm x Kits Contents : Percutaneous Sheath Introducer with Sideport Haemostasis Valve OD 3.70mm x ID 2.90mmx 10cm and Dilator, guidewire 0.9x450mm, Introducers 1.4x70mm, stopcock

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More Product Details

Catalog Number

680156

Brand Name

SHEATH INTRO POP KIT 9FR L5 MULT=5/50

Version/Model Number

680156

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

dfb2a28b-f773-4f85-8e00-f5c7ba52f73d

Public Version Date

March 05, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

50886333601566

Quantity per Package

50

Contains DI Package

00886333601561

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