Single Use Professional

Rounded Suction 12fg 30cm 60° 4x1mm Fen contains 25 units

Registry build 21.09.26
30manufacturers in China registered for this device type
168catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (8), Jiangsu (7), Guangdong (7). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GCX
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Dongguan Junhai Medical Device Co., Ltd. Dong Guang Guangdong Contract manufacturer 9
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Saferlife Products Co., Ltd. Guangzhou Guangdong Contract manufacturer 58
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Amsino Medical (Kunshan) Co., Ltd. Kunshan Jiangsu Contract manufacturer 53
Infitek Co., Ltd. Shanghai Shanghai Manufacturer 49
Rusun Medical Co., Ltd. Yichun Jiangxi Manufacturer 37
Jiangsu JianYu Health Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 35
Tianjin Tairuibosi Medical Appliance Co., Ltd. Tianjin Tianjin Private-label distributor 30

Showing 12 of 30. All 30 manufacturers in China registered for Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Record

Regulatory record for Single Use Professional
Listed by Eakin Surgical Ltd, United Kingdom
FDA product code GCX
Device type Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device class Class 2
Regulation 21 CFR 880.6740
Establishment Manufacturer
Premarket notification Exempt
Record published 2024-02-18
Record revised 2024-04-08 (version 9)

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, manufacturing date
Sizes Catheter gauge 3 to 15 Fr; length 5 to 300 cm; angle 60 to 90 °; needle gauge 18 to 24 G; outer diameter 3 to 8 mm
Distribution end date 2023-10-23

Catalogue Numbers

Catalogue numbers for Single Use Professional
Catalogue number Size Status
5fgN140 In distribution
S466 In distribution
S071 Catheter Gauge 6 Fr In distribution
S464 In distribution
S001 Catheter Gauge 9 Fr In distribution
OPR009 In distribution
8fgN100 In distribution
S469 In distribution
S076 Catheter Gauge 9 Fr In distribution
S229 Angle 70 ° In distribution
S445 In distribution
S010 In distribution
S041 Catheter Gauge 12 Fr In distribution
S133 Length 13 cm In distribution
S094 Length 13 cm In distribution
S139 Catheter Gauge 6 Fr In distribution
S193 Length 13 cm In distribution
S040 Angle 90 ° In distribution
S434 Length 7 cm In distribution
S467 In distribution
S160 Length 5 cm In distribution
S465 In distribution
S091 Catheter Gauge 6 Fr In distribution
S104 Catheter Gauge 12 Fr In distribution
OPR005 In distribution
OPR008 In distribution
S043 Catheter Gauge 12 Fr In distribution
S461 In distribution
6fgN100 Catheter Gauge 6 Fr In distribution
S187 Length 35 cm In distribution
S456 In distribution
S458 In distribution
S470 In distribution
OPR010 In distribution
S011 Length 27 cm In distribution
S095 Catheter Gauge 6 Fr In distribution
S435 Length 12 cm In distribution
S026 Catheter Gauge 12 Fr In distribution
S190 Length 9 cm In distribution
OPR009 In distribution
S013 Angle 70 ° In distribution
S093 Catheter Gauge 12 Fr In distribution
S457 In distribution
S460 In distribution
S466 In distribution
S451 In distribution
S340 Length 9 cm In distribution
S038 Catheter Gauge 12 Fr In distribution
S183 Catheter Gauge 9 Fr In distribution
S036 Catheter Gauge 9 Fr In distribution
S452 In distribution
S184 Length 55 cm In distribution
S192 Catheter Gauge 9 Fr In distribution
S102 Catheter Gauge 6 Fr In distribution
S228 Catheter Gauge 9 Fr In distribution
S096 Length 13 cm In distribution
S318 Length 20 cm In distribution
6fgF140 Catheter Gauge 6 Fr In distribution
9fgF140 Catheter Gauge 9 Fr In distribution
S230 Catheter Gauge 9 Fr In distribution
OPR003 In distribution
S015 Length 45 cm In distribution
S024 Catheter Gauge 9 Fr In distribution
S111 Length 55 cm In distribution
S319 Catheter Gauge 9 Fr In distribution
S066 Length 50 cm In distribution
6fgN140 Catheter Gauge 6 Fr In distribution
S285 Length 11 cm In distribution
S459 In distribution
S436 Catheter Gauge 12 Fr In distribution
10fgN140 In distribution
S005 Catheter Gauge 9 Fr In distribution
OPR003 In distribution
S147 Catheter Gauge 12 Fr In distribution
S446 In distribution
S390 Length 13 cm In distribution
OPR010 In distribution
S165 Catheter Gauge 6 Fr In distribution
S169 Angle 60 ° In distribution
S031 Catheter Gauge 6 Fr In distribution
S074 Catheter Gauge 12 Fr In distribution
S012 Catheter Gauge 9 Fr In distribution
S132 Catheter Gauge 12 Fr In distribution
S034 Length 9 cm In distribution
10fgN100 In distribution
S109 Length 40 cm In distribution
S458 In distribution
S075 Length 17 cm In distribution
S461 In distribution
S072 Length 6 cm In distribution
S470 In distribution
S101 Length 150 cm In distribution
S454 In distribution
S156 Length 20 cm In distribution
OPR006 In distribution
S177 Catheter Gauge 5 Fr In distribution
S037 Length 9 cm In distribution
S189 Catheter Gauge 9 Fr In distribution
S440 Catheter Gauge 12 Fr In distribution
S008 Needle Gauge 24 G In distribution
S146 Length 12 cm In distribution
S444 In distribution
5fgN100 In distribution
S020 Catheter Gauge 6 Fr In distribution
S471 In distribution
7fgN100 In distribution
S163 Catheter Gauge 12 Fr In distribution
S471 In distribution
S042 Length 13 cm In distribution
S231 Angle 90 ° In distribution
9fgN100 Catheter Gauge 9 Fr In distribution
S455 In distribution
S099 Length 300 cm In distribution
S240 Length 15 cm In distribution
OPR001 In distribution
S459 In distribution
OPR001 In distribution
S321 Length 9 cm In distribution
S453 In distribution
S460 In distribution
S447 In distribution
S007 Length 6 cm In distribution
S446 In distribution
OPR005 In distribution
OPR006 In distribution
OPR004 In distribution
S014 Catheter Gauge 9 Fr In distribution
S469 In distribution
S343 Catheter Gauge 12 Fr In distribution
S199 Catheter Gauge 12 Fr In distribution
S258 Catheter Gauge 6 Fr In distribution
S055 Catheter Gauge 6 Fr In distribution
S120 Catheter Gauge 6 Fr In distribution
S284 Catheter Gauge 12 Fr In distribution
S092 Length 9 cm In distribution
S168 Length 20 cm In distribution
S439 Needle Gauge 18 G In distribution
S456 In distribution
S087 Length 5 cm In distribution
S157 Needle Gauge 20 G In distribution
S457 In distribution
S103 Length 7 cm In distribution
OPR002 In distribution
S176 Length 8 cm In distribution
9fgN140 Length 9 cm In distribution
S464 In distribution
S028 In distribution
S060 Length 9 cm In distribution
S131 Angle 60 ° In distribution
S465 In distribution
S236 Catheter Gauge 12 Fr In distribution
8fgN140 In distribution
S086 Catheter Gauge 6 Fr In distribution
S185 Catheter Gauge 6 Fr In distribution
S110 Catheter Gauge 6 Fr In distribution
S445 In distribution
S447 In distribution
S444 In distribution
S021 Length 20 cm In distribution
S002 Length 9 cm In distribution
S182 Length 27 cm In distribution
7fgN140 In distribution
S077 Length 13 cm In distribution
OPR004 In distribution
OPR002 In distribution
OPR007 In distribution
OPR007 In distribution
S329 Catheter Gauge 12 Fr Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Vacutron Allied Medical LLC 764
Cardinal Health Cardinal Health 200, LLC 310
Aesculap Aesculap AG 243
Medi-VAC Cardinal Health 200, LLC 158
MSI Precision Specialty Instruments MED Saver, Inc. 121
Du-O-Vac W.T. Farley, Inc. 91
Ambler Surgical Ambler Surgical, LLC 66
Apparatus, Suction, Operating-Room, Wall Vacuum Powered Biomet Microfixation 65
Wexler Surgical, Inc. Wexler Surgical, Inc. 44
OMT LLC OMT, LLC 39
Argyle Cardinal Health 38
Argyle Cardinal Health 200, LLC 34

Showing 12 of 257. All products under Apparatus, Suction, Operating-Room, Wall Vacuum Powered

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