Total Abscession

6.5F x 15cm Total Abscession General Drainage Catheter (Locking Pigtail)

Registry build 21.09.26
24manufacturers in China registered for this device type
36catalogue numbers in this listing

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 Total Abscession
Listed by AngioDynamics, Inc., United States
FDA product code GBX
Device type Catheter, Irrigation
Device class Class 1
Regulation 21 CFR 878.4200
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-10-30
Record revised 2024-10-31 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Storage environment temperature up to 27 °C
Packaging Box of 5
Sizes Catheter gauge 6.5 to 14 Fr; length 15 to 45 cm
Distribution end date 2024-10-30

Catalogue Numbers

Catalogue numbers for Total Abscession
Catalogue number Size Status
H787140008070 Catheter Gauge 8 Fr In distribution
H787140008260 Catheter Gauge 14 Fr In distribution
H787140008230 Length 30 cm In distribution
H787140008080 Catheter Gauge 10 Fr In distribution
H787140008300 Catheter Gauge 14 Fr In distribution
H787140008090 Length 45 cm In distribution
H787140008240 Catheter Gauge 10 Fr In distribution
H787140008050 Length 30 cm In distribution
H787140008270 Length 45 cm In distribution
H787140008290 Catheter Gauge 12 Fr In distribution
H787140008060 Length 30 cm In distribution
H787140008280 Length 45 cm In distribution
H787140008010 Catheter Gauge 6.5 Fr In distribution
H787140008250 Length 30 cm In distribution
H787140008020 Length 30 cm In distribution
H787140008100 Length 45 cm In distribution
H787140008040 Length 30 cm In distribution
H787140008030 Catheter Gauge 8 Fr In distribution
14000824 Length 30 cm Withdrawn
14000809 Catheter Gauge 12 Fr Withdrawn
14000807 Length 45 cm Withdrawn
14000828 Catheter Gauge 10 Fr Withdrawn
14000827 Catheter Gauge 8 Fr Withdrawn
14000825 Length 30 cm Withdrawn
14000810 Catheter Gauge 14 Fr Withdrawn
14000805 Length 30 cm Withdrawn
14000823 Length 30 cm Withdrawn
14000803 Length 30 cm Withdrawn
14000829 Length 45 cm Withdrawn
14000801 Length 15 cm Withdrawn
14000808 Catheter Gauge 10 Fr Withdrawn
14000830 Length 45 cm Withdrawn
14000802 Length 30 cm Withdrawn
14000804 Catheter Gauge 10 Fr Withdrawn
14000806 Length 30 cm Withdrawn
14000826 Length 30 cm Withdrawn

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
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
Thoracentesis and Paracentesis Set Merit Medical Systems, Inc. 17

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