Tessys®

TESSYS® Guiding Tube, conical, violet

Registry build 21.09.26
26manufacturers in China registered for this device type
26catalogue 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 Tessys®
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 Tessys®
Catalogue number Size Status
GRB221540 L 220 mm / ID 1.5 mm / OD 4.0 mm In distribution
GRB221025 L 220 mm / ID 1.0 mm / OD 2.5 mm In distribution
WTS217500 fenestrated, L 208 mm / ID 6.5 mm / OD 7.5 mm In distribution
TCW40010 L 400 mm / OD 1.0 mm In distribution
GRC242050 L 240 mm / ID 2.1 mm / OD 5.2 mm In distribution
GRC222050 L 220 mm / ID 2.0 mm / OD 5.0 mm In distribution
GTC176573 L 175 mm / ID 6.5 mm / OD 7.3 mm In distribution
GRB222050 L 220 mm / ID 2.0 mm / OD 5.0 mm In distribution
GTC194353 L 195 mm / ID 4.2 mm / OD 5.2 mm In distribution
GTC185363 L 185 mm / ID 5.3 mm / OD 6.3 mm In distribution
GRC221540 L 220 mm / ID 1.5 mm / OD 4.0 mm In distribution
GRC221025 L 220 mm / ID 1.0 mm / OD 2.5 mm In distribution
GRT241025S L 240 mm / ID 1.0 mm / OD 2.5 mm In distribution
GRC241025 L 240 mm / ID 1.0 mm / OD 2.5 mm In distribution
GTC182840 L 180 mm / ID 2.8 mm / OD 4.0 mm In distribution
GRB252050 L 250 mm / ID 2.0 mm / OD 5.0 mm In distribution
GRB251540 L 250 mm / ID 1.5 mm / OD 4.0 mm In distribution
WTS217503 fenestrated 45°, L 208 mm / ID 6.5 mm / OD 7.5 mm In distribution
GRF182500 WL 180 mm / bore for 2.5 mm and 4.0 mm guiding rod In distribution
GRF182500 * WL 143mm / for 2.5/4.0/5.2mm Guiding rod In distribution
GTC155260 L 150 mm / ID 5.2 mm / OD 6.0 mm In distribution
GRB251025 L 250 mm / ID 1.0 mm / OD 2.5 mm In distribution
GRT221025S L 220 mm / ID 1.0 mm / OD 2.5 mm In distribution
GRC241540 L 240 mm / ID 1.5 mm / OD 4.0 mm In distribution
GTC202838 L 205 mm / ID 2.6 mm / OD 3.9 mm In distribution
GTC164250 L 165 mm / ID 4.2 mm / OD 5.0 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