Shoocin - The Puncture Needle incorporates a lumen, which - Lepu Medical Technology (Beijing) Co.,Ltd.

Duns Number:529853921

Device Description: The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of th The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guide Wire into the vascular system. The flexible stainless-steel guide wire is utilized as a guiding mechanism for the insertion of the Introducer Sheath into the vascular system. The Guide Wire contains a wire collimator, which assists in funneling thewire through the lumen of the Puncture Needle. The Guide Wire is radio-detective under fluoroscopy. The Sheath Introducer contains Barium sulfate (BaSO4), making the device visible under fluoroscopy and provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vascular system. The main components of this assembly are a non-hydrophilic coated Sheath Introducer, hemostasis valve housing, and a side port tubing with a 3-way stopcock/valve. The 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. There is no radiocontrast agent on the dilator.

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More Product Details

Catalog Number

-

Brand Name

Shoocin

Version/Model Number

RS040725S-II

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

246f43ed-da6f-4caa-b020-b7c5c522f7ff

Public Version Date

June 07, 2019

Public Version Number

2

DI Record Publish Date

May 13, 2019

Additional Identifiers

Package DI Number

16936733740801

Quantity per Package

5

Contains DI Package

06936733740804

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