Shoocin

"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…

Registry build 21.09.26

“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.

13manufacturers in China registered for this device type
89catalogue numbers in this listing
3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DYB
Manufacturer City Province Registered as Device types
Mehow Innovative (Huizhou) Ltd. Huizhou Guangdong Contract manufacturer 11
Tianjin Demax Medical Technology Co., Ltd. Tianjin Tianjin Contract manufacturer 5
Steris Sterilization Technologies (Suzhou) Ltd Suzhou Jiangsu Contract manufacturer 44
Shanghai INT Medical Instruments Co., Ltd. Shanghai Shanghai Contract manufacturer 10
Lepu Medical Technology (Beijing) Co., Ltd. Beijing Beijing Manufacturer 7
Beijing Target Medical Technologies Inc. Beijing Beijing Contract manufacturer 7
Beijing Demax Medical Technology Co., Ltd. Beijing Beijing Manufacturer 5
Curatia Medical Limited Suzhou Jiangsu Specification developer 5
Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. Tianjin Tianjin Contract manufacturer 4
Shanghai Microport EP Medtech Co., Ltd. Shanghai Shanghai Manufacturer 3
Becton Dickinson Medical Devices Co., Ltd. Suzhou Suzhou Jiangsu Contract manufacturer 2
Cardiocycle Medical(Suzhou) Co., Ltd. Suzhou Jiangsu Complaint-file establishment 1

Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter

Record

Regulatory record for Shoocin
Listed by Lepu Medical Technology (Beijing) Co., Ltd., China
FDA product code DYB
Device type Introducer, Catheter
Device class Class 2
Regulation 21 CFR 870.1340
Establishment Manufacturer
Record published 2018-08-17
Record revised 2024-03-20 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Box of 5, pack of 5

Catalogue Numbers

Catalogue numbers for Shoocin
Catalogue number Size Status
RS061118 In distribution
RS041118S-II In distribution
LS082338 In distribution
FS051138 In distribution
RS070718 In distribution
RS050725S In distribution
RS060718S In distribution
RS040718 In distribution
FS081135-0 In distribution
RS070525 In distribution
LS081638 In distribution
RS050718S In distribution
FS061138 In distribution
RS070521 In distribution
RS050518S In distribution
RS061118S In distribution
RS040725S-II In distribution
RS040725 In distribution
RS040718S-II In distribution
RS071118S-II In distribution
RS040521 In distribution
FS060535 In distribution
RS040518 In distribution
LS072338 In distribution
RS040718S In distribution
FS050535 In distribution
RS040518S-II In distribution
RS040721S In distribution
FS051135 In distribution
RS061118S-II In distribution
RS060518S-II In distribution
LS071638 In distribution
RS040525 In distribution
RS060521 In distribution
RS060721 In distribution
RS040721S-II In distribution
RS071118S In distribution
FS071135-0 In distribution
RS051118S In distribution
FS111138 In distribution
RS050518 In distribution
RS060725S In distribution
LS062338 In distribution
FS061135-0 In distribution
FS061135 In distribution
RS050721 In distribution
LS061638 In distribution
RS070518 In distribution
RS060518S In distribution
RS050525 In distribution
RS071118 In distribution
RS040725S In distribution
RS060718 In distribution
RS050718S-II In distribution
FS041125 In distribution
RS060721S-II In distribution
RS050725 In distribution
RS051118 In distribution
RS051118S-II In distribution
RS040518S In distribution
RS060725S-II In distribution
FS041135 In distribution
RS060725 In distribution
RS070718S-II In distribution
RS050518S-II In distribution
RS050521 In distribution
RS040721 In distribution
RS041118S In distribution
RS050721S In distribution
RS050725S-II In distribution
RS060518 In distribution
FS051135-0 In distribution
FS071135 In distribution
RS060718S-II In distribution
FS081138 In distribution
FS080535 In distribution
FS091138 In distribution
FS101138 In distribution
RS060721S In distribution
RS041118 In distribution
RS060525 In distribution
FS070535 In distribution
RS050718 In distribution
RS070718S In distribution
RS070518S In distribution
FS071138 In distribution
FS081135 In distribution
RS070518S-II In distribution
RS050721S-II In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Demax Beijing Demax Medical Technology Co., Ltd. 2,841
Arrow Teleflex Medical LLC 1,036
Prelude IDeal™ Merit Medical Systems, Inc. 294
Fast-Cath™ St. Jude Medical 213
Flexor Cook Incorporated 182
Prelude Ease™ Merit Medical Systems, Inc. 176
Performer Cook Incorporated 174
VSI Teleflex Medical LLC 154
Peel-Away Cook Incorporated 153
OptiSeal™ Greatbatch Medical 127
Brilliant Lepu Medical Technology (Beijing) Co., Ltd. 122
Super Sheath Togo Medikit Co., Ltd. 122

Showing 12 of 439. All products under Introducer, Catheter

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K172331 2018-03-02
K172099 2017-10-05
K123475 2014-02-03

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer