Brilliant - The puncture needle or an intravascular catheter - Lepu Medical Technology (Beijing) Co.,Ltd.

Duns Number:529853921

Device Description: The puncture needle or an intravascular catheter incorporates a lumen, which provides a co The puncture needle or an intravascular catheter incorporates a lumen, which provides a conduit for the insertion of the guide wire into the vascular system. The various types of guide wires, model dependent, are utilized as a guiding mechanism for the insertion of the introduction sheath into the vascular system. The guide wire contains a wire collimator, which assists in funneling the wire through the lumen of the puncture needle or the intravascular catheter and contains marking that are visible under fluoroscopy, which can determine the length of the guide wire within the vascular system. The sheath introducer provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vasculature. The main components of the sheath introducer assembly are a hydrophilic coated sheathintroducer, hemostasis valve housing, and a side port with tubing connected to a 3-way stopcock/valve. The hydrophilic coated dilator is used to provide support and stability to the sheath introducer during deployment into the vascular system. The proximal end of the dilator includes a luer port and has a tapered, atraumatic distal tip. Both the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.

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


More Product Details

Catalog Number

-

Brand Name

Brilliant

Version/Model Number

CS070718

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

-

Product Code Details

Product Code

DYB

Product Code Name

Introducer, Catheter

Device Record Status

Public Device Record Key

646dedea-4da9-4149-ae3f-fb80ad0d6636

Public Version Date

June 07, 2019

Public Version Number

2

DI Record Publish Date

November 16, 2018

Additional Identifiers

Package DI Number

16936733738044

Quantity per Package

5

Contains DI Package

06936733738047

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"LEPU MEDICAL TECHNOLOGY (BEIJING) CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 89