Shoocin

GUDID 16936733740849

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 the wire 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.

Lepu Medical Technology (Beijing) Co.,Ltd.

Vascular catheter introduction set, nonimplantable
Primary Device ID16936733740849
NIH Device Record Key8c91cfda-0750-4fc4-bdae-23db238e8175
Commercial Distribution StatusIn Commercial Distribution
Brand NameShoocin
Version Model NumberRS050721S-II
Company DUNS529853921
Company NameLepu Medical Technology (Beijing) Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106936733740842 [Primary]
GS116936733740849 [Package]
Contains: 06936733740842
Package: Box [5 Units]
In Commercial Distribution

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-06-07
Device Publish Date2019-05-13

On-Brand Devices [Shoocin]

16936733740191The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733740184The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733740177The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733740160The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733740153The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733740146The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733740139The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733740122The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733740115The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733740108The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733740009The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733739997The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733739980The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733739973The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733739966The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733739959The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733739942The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733739935The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733739874The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733739867The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733739850The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733737573The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733737559The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733737535The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733737511The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733737481The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733737375The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733737368The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733737351"The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire coll
16936733737344"The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire coll
16936733737337"The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire coll
16936733737320"The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire coll
16936733737313"The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire coll
16936733737306"The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire coll
16936733737290"The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire coll
16936733737283"The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire coll
16936733737276The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire colli
16936733737269"The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire coll
16936733740924The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guid
16936733740917The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guid
16936733740900The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guid
16936733740894The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guid
16936733740887The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guid
16936733740870The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guid
16936733740863The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guid
16936733740856The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guid
16936733740849The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guid
16936733740832The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guid
16936733740825The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guid
16936733740818The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guid
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.