TSI

Instrument Tray, Ancillary Items, Single Level, Medium

Registry build 21.09.26
105manufacturers in China registered for this device type
69catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (28), Zhejiang (23), Shanghai (16). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FSM
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Danyang Jiangsu Contract manufacturer 37
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Mobility Source Medical Technology Co., Ltd. Foshan Guangdong Contract manufacturer 26
Guangdong Shunde LQX Health Technology Inc. Foshan Guangdong Contract manufacturer 24

Showing 12 of 105. All 105 manufacturers in China registered for Tray, Surgical, Instrument

Record

Regulatory record for TSI
Listed by Tedan Surgical Innovations, L.L.C.
FDA product code FSM
Device type Tray, Surgical, Instrument
Device class Class 1
Regulation 21 CFR 878.4800
Premarket notification Exempt
Record published 2017-08-09
Record revised 2023-08-25 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number, manufacturing date
Sizes Length 16.5 cm
Distribution end date 2023-09-14

Catalogue Numbers

Catalogue numbers for TSI
Catalogue number Size Status
CS-0205 In distribution
ML-0708-01 In distribution
ML-0700-02 In distribution
TK-0700-02 Length 16.5 cm In distribution
UT-0703 In distribution
TK-0600 Length 16.5 cm In distribution
UL-0709 In distribution
KR-0700 In distribution
AL-0700-01 In distribution
LS-0704 In distribution
ML-0713-02 In distribution
UL-0706 In distribution
ML-0708-03 In distribution
LS-0700 In distribution
CS-0600L In distribution
VPR0700 In distribution
CS-0604 In distribution
LS-0703 In distribution
UT-0702 In distribution
LS-0800L In distribution
LS-0900 In distribution
CT-0701 In distribution
UT-0701 In distribution
ML-0711 In distribution
CS-0400 In distribution
ML-0715 In distribution
ML-0700-01 In distribution
GS-0600 In distribution
UL-0707 In distribution
ML-0708-02 In distribution
TK-0700-01 Length 16.5 cm In distribution
UL-0703 In distribution
UL-0708 In distribution
CT-0702 In distribution
ML-0709 In distribution
LS-0701 In distribution
AL-0700-02 In distribution
TK-0700-03 Length 16.5 cm In distribution
UL-0705 In distribution
ML-0713-01 In distribution
ML-0710 In distribution
UL-0701 In distribution
LS-0800-05 In distribution
ML-0704 In distribution
UL-0704 In distribution
ML-0705-01 In distribution
UL-0700 In distribution
ML-0714 In distribution
LS-0800 In distribution
UL-0702 In distribution
CS-0600 In distribution
CT-0705 In distribution
BW-0700-01 Withdrawn
ML-0703 Withdrawn
CS-0605 Withdrawn
BW-0700-02 Withdrawn
ML-0705 Withdrawn
LS-0705 Withdrawn
ML-0712 Withdrawn
CS-0600-05 Withdrawn
CS-0606 Withdrawn
HS-0700-02 Withdrawn
CT-0704 Withdrawn
CS-0602 Withdrawn
CS-0900 Withdrawn
CT-0700 Withdrawn
HS-0700-01 Withdrawn
ML-0708-023 Withdrawn
CS-0602L Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
IMS HU-Friedy MFG Co., LLC 2,710
Tray, Surgical, Instrument Synthes Gmbh 1,052
Tray, Surgical, Instrument Medtronic Sofamor Danek, Inc. 1,012
Hu-Friedy MFG Co., LLC. HU-Friedy MFG Co., LLC 666
Aptus Medartis Inc. 588
Acumed Acumed LLC 566
Aesculap Aesculap AG 532
Sklar Sklar Corporation 465
Hu-Friedy HU-Friedy MFG Co., LLC 438
Nordent Manufacturing Inc Nordent Manufacturing Inc 429
Level ONE KLS-Martin L.P. 341
Bahadir USA Bahadir USA LLC 300

Showing 12 of 3,212. All products under Tray, 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