iLESSYS®

iLESSYS® Pro Guiding Tube,beveled 45°,edged,yellow

Registry build 21.09.26
26manufacturers in China registered for this device type
20catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Zhejiang (5), Guangdong (4). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FZX
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Turnxon Precision Co., Ltd. Dongguan Guangdong Contract manufacturer 17
Beilun Plastech Inc Ningbo Zhejiang Contract manufacturer 13

Showing 12 of 26. All 26 manufacturers in China registered for Guide, Surgical, Instrument

Record

Regulatory record for iLESSYS®
Listed by Joimax Gmbh, Germany
FDA product code FZX
Device type Guide, Surgical, Instrument
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2022-12-30

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for iLESSYS®
Catalogue number Size Status
GRD187350 L 180mm /ID 5.0mm /OD 7.3mm,longitudinally slotted In distribution
GRC212549 L 210 mm / ID 2.5 mm / OD 4.9 mm In distribution
GTC214069 L 210 mm / ID 4.0 mm / OD 6.9 mm In distribution
SWTDR1009 for Endoscopes with OD 10 mm In distribution
WTS901304.3 L 91 mm / ID 10.2 mm / OD 13.7 mm, stainless steel In distribution
GTC17701045 L 170 mm / ID 7.0 mm / OD 10.0 mm In distribution
WTS217500 * WL 5 mm / OD 12 mm / ID 6.50 mm In distribution
GRHC607958 L 60 mm / ID 5.9 mm In distribution
GRC175073 L 170 mm / ID 5.0 mm / OD 7.3 mm In distribution
SWTDR7325 L 25 mm / for Endoscopes with OD 7.3 mm In distribution
GRC260024 L 260 mm / OD 2.4 mm In distribution
WTS127507 L 125 mm / ID 6.5 mm / OD 7.5 mm In distribution
WTS901300 L 91mm /ID 10.2mm /OD 13.7mm, radiolucent In distribution
WTS901300.3 L 91 mm / ID 10.2 mm / OD 13.7 mm, stainless steel In distribution
WTS127007 L 124 mm / ID 6.0 mm / OD 7.0 mm In distribution
WTS121602 L 132 mm / ID 15 mm / OD 16 mm In distribution
WTA901300.1 L 7 mm / ID 14 mm / OD 22 mm In distribution
SWTDR7330 L 30 mm / for Endoscopes with OD 7.3 mm In distribution
WTS901304 L 91mm /ID 10.2mm /OD 13.7mm, radiolucent In distribution
WTA901300.S L 11 mm / ID 10.2 mm / OD 22 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DJO Surgical Encore Medical, L.P. 2,141
Guide, Surgical, Instrument Synthes Gmbh 727
DJO Surgical DJO, LLC 284
Apex Knee System Omni Life Science, Inc. 272
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 223
Motoband CP Crossroads Extremity Systems LLC 221
Advance® Microport Orthopedics Inc. 199
NexGen® Zimmer, Inc. 194
Evolution® Microport Orthopedics Inc. 173
Innomed, Inc. Innomed, Inc. 172
Newclip Instruments Newclip Technics SAS 144
Guide, Surgical, Instrument Zimmer, Inc. 135

Showing 12 of 1,788. All products under Guide, Surgical, Instrument

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