Irrigation Set for Rtup Diagnostic

Catalogue number GL0201T2S, listed by Promepla, United States, under Catheter, Irrigation. 24 manufacturers in China are registered for this product code.

Registry build 21.09.26
24manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (7), Zhejiang (7), Guangdong (5). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GBX
Manufacturer City Province Registered as Device types
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Zhejiang Baite Medical Appliances Co., Ltd. Huzhou Zhejiang Contract manufacturer 13
Medwell Technology Limited Dongguan Guangdong Contract manufacturer 10
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Zhejiang Lidesen Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 100
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65

Showing 12 of 24. All 24 manufacturers in China registered for Catheter, Irrigation

Record

Regulatory record for Irrigation set for Rtup Diagnostic
Listed by Promepla, United States
FDA product code GBX
Device type Catheter, Irrigation
Device class Class 1
Regulation 21 CFR 878.4200
Premarket notification Exempt
Record published 2016-09-14
Record revised 2019-04-23 (version 4)

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 2 of 4, box 1 of 10

Catalogue Numbers

Catalogue numbers for Irrigation set for Rtup Diagnostic
Catalogue number Size Status
GL0201T2S In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
One-Step™ Merit Medical Systems, Inc. 167
Cardinal Health Cardinal Health 200, LLC 109
Cook Cook Incorporated 85
ReSolve® Merit Medical Systems, Inc. 68
Pleur-Evac Teleflex Medical LLC 66
Jackson-Pratt Cardinal Health 200, LLC 47
Total Abscession AngioDynamics, Inc. 36
Channel Drain C.R. Bard, Inc. 36
ReSolve Mini™ Merit Medical Systems, Inc. 32
Silicone Tubing, Radiopaque Bentec Medical OpCo, LLC. 25
Blake Ethicon, Inc. 19
Silicone Tubing, Translucent Bentec Medical OpCo, LLC. 19

Showing 12 of 223. All products under Catheter, Irrigation

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