Shoocin

Primary DI
06941785291198
Brand
Shoocin
Company
Lepu Medical Technology (Beijing) Co.,Ltd.
Model
FS050535
Device description
The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire collimator, a sheath introducer, and a dilator. 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 fluoroscopyand 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.
Published
2025-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16941785291195PackageGS15In Commercial Distribution
06941785291198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694178529119516941785291195
06941785291198069417852911986941785291198

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529853921
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
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06936733736951ULTRASKINST-S351802026-07-10
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06936733738207BrilliantACS0607212026-04-16
06936733738214BrilliantACS0624212026-04-16
06936733738221BrilliantACS0607352026-04-16
06936733738238BrilliantACS0611352026-04-16
06936733738245BrilliantACS0616352026-04-16
06936733738252BrilliantACS0624352026-04-16
06936733738276BrilliantACS0711352026-04-16
06936733738283BrilliantACS0716352026-04-16
06936733738290BrilliantACS0724352026-04-16
06936733738306BrilliantRSC0407212026-04-16
06936733738313BrilliantRSC040721A2026-04-16
06936733738320BrilliantRSC0407252026-04-16
06936733738337BrilliantRSC0411212026-04-16
06936733738344BrilliantRSC041121A2026-04-16
06936733738351BrilliantRSC0411252026-04-16
06936733738368BrilliantRSC0416212026-04-16
06936733738375BrilliantRSC041621A2026-04-16
06936733738382BrilliantRSC0416252026-04-16

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