Shoocin
- Primary DI
- 06936733740149
- Brand
- Shoocin
- Company
- Lepu Medical Technology (Beijing) Co.,Ltd.
- Model
- RS060721S
- 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 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.
- Published
- 2018-09-02
- Public version status
- Update
- 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 |
|---|---|
| DYB | Introducer, Catheter |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 16936733740146 | Package | GS1 | 5 | In Commercial Distribution |
| 06936733740149 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 16936733740146 | 16936733740146 | |
| 06936733740149 | 06936733740149 | 6936733740149 |
GMDN Terms#
| Term | Definition |
|---|---|
| Vascular catheter introduction set, nonimplantable | A 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. |
Regulatory Flags#
- DUNS number
- 529853921
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
- No natural rubber latex
- true
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| 06936733738191 | Brilliant | ACS052421 | 2026-04-16 | |
| 06936733738207 | Brilliant | ACS060721 | 2026-04-16 | |
| 06936733738214 | Brilliant | ACS062421 | 2026-04-16 | |
| 06936733738221 | Brilliant | ACS060735 | 2026-04-16 | |
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| 06936733738290 | Brilliant | ACS072435 | 2026-04-16 | |
| 06936733738306 | Brilliant | RSC040721 | 2026-04-16 | |
| 06936733738313 | Brilliant | RSC040721A | 2026-04-16 | |
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| 06936733738368 | Brilliant | RSC041621 | 2026-04-16 | |
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