Introducer, Catheter

13F X 44CM Ptfe Long Tear Away Introducr

Registry build 21.09.26
13manufacturers in China registered for this device type
74catalogue numbers in this listing

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 Introducer, Catheter
Listed by B. Braun Interventional Systems, Inc., United States
FDA product code DYB
Device type Introducer, Catheter
Device class Class 2
Regulation 21 CFR 870.1340
Record published 2016-08-09
Record revised 2024-03-20 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Storage Special storage condition: Store at room temp; Special storage condition: Store in a dry place; Special storage condition: Store in a dark place

Catalogue Numbers

Catalogue numbers for Introducer, Catheter
Catalogue number Size Per pack Status
612645 10 In distribution
612649 10 In distribution
612641 5 In distribution
612650 10 In distribution
612647 10 In distribution
612638 5 In distribution
612626 10 In distribution
612644 5 In distribution
612796 10 In distribution
612825 10 In distribution
612798 10 In distribution
612826 10 In distribution
612608 5 In distribution
612631 5 In distribution
612852 5 In distribution
612616 10 In distribution
612853 5 In distribution
612627 5 In distribution
612606 5 In distribution
612636 5 In distribution
612827 10 In distribution
612600 5 In distribution
612832 10 In distribution
612602 5 In distribution
612782 10 In distribution
612642 5 In distribution
612609 5 In distribution
612791 5 In distribution
612780 10 In distribution
612624 10 In distribution
612610 5 In distribution
612632 5 In distribution
612623 10 In distribution
612795 10 In distribution
612799 10 In distribution
612830 10 In distribution
612648 10 In distribution
612637 5 In distribution
612611 5 In distribution
612635 5 In distribution
612829 10 In distribution
612783 10 In distribution
612622 10 In distribution
612612 5 In distribution
612620 10 In distribution
612634 5 In distribution
612828 10 In distribution
612633 5 In distribution
612613 5 In distribution
612794 10 In distribution
612604 5 In distribution
612614 5 In distribution
612646 10 In distribution
612617 10 In distribution
612831 10 In distribution
612628 5 In distribution
612601 5 In distribution
612640 5 In distribution
612643 5 In distribution
612621 10 In distribution
612603 5 In distribution
612625 10 In distribution
612850 5 In distribution
612639 5 In distribution
612619 10 In distribution
612790 5 In distribution
612792 5 In distribution
612615 5 In distribution
612793 5 In distribution
612781 10 In distribution
612629 5 In distribution
612851 5 In distribution
612630 5 In distribution
612797 10 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

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