TSI

Pivoting Scoville Side-Load Retractor, 200 MM Rack

Registry build 21.09.26
34manufacturers in China registered for this device type
65catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (7), Zhejiang (6). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GAD
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74

Showing 12 of 34. All 34 manufacturers in China registered for Retractor

Record

Regulatory record for TSI
Listed by Tedan Surgical Innovations, L.L.C.
FDA product code GAD
Device type Retractor
Device class Class 1
Regulation 21 CFR 878.4800
Premarket notification Exempt
Record published 2017-08-16
Record revised 2018-12-21 (version 3)

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
Distribution end date 2023-06-14

Catalogue Numbers

Catalogue numbers for TSI
Catalogue number Size Status
CS-0097 In distribution
CS-0200 In distribution
CS-0321 In distribution
CS-0202 In distribution
VPR0501 In distribution
CS-0101 In distribution
ML-0312 In distribution
CS-0102 In distribution
CS-0210 In distribution
CS-0311 In distribution
ML-0204 In distribution
ML-0211 In distribution
CS-0108 In distribution
CS-0103 In distribution
LS-0451 In distribution
ML-0210 In distribution
CS-0201 In distribution
ML-0318 In distribution
ML-0320 In distribution
LS-0449 In distribution
ML-1152 In distribution
AL-0106 In distribution
CS-0104 In distribution
CS-0107 In distribution
ML-0207 In distribution
ML-0505 In distribution
ML-0784 In distribution
CS-0322 In distribution
ML-0200 In distribution
CS-0314 In distribution
LS-0398 In distribution
ML-0202 In distribution
ML-1156 In distribution
LS-0402 In distribution
CS-0320 In distribution
CS-0218 In distribution
ML-0212 In distribution
ML-0905 In distribution
CS-0220 In distribution
LS-0450 In distribution
VPR0200 In distribution
ML-0199 In distribution
ML-0316 In distribution
CS-0096 In distribution
ML-0322 In distribution
ML-0518 In distribution
LS-0300 In distribution
ML-0208 In distribution
CS-0099 In distribution
CS-0100 In distribution
ML-0782 In distribution
CS-0223 In distribution
CS-0310 In distribution
ML-0201 In distribution
CS-0098 In distribution
LS-0100 In distribution
ML-0314 In distribution
VPR0225 In distribution
LS-0101 In distribution
ML-0310 In distribution
ML-0203 Withdrawn
ML-0502 Withdrawn
LS-0200 Withdrawn
ML-0500 Withdrawn
MD-1468 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Thompson Thompson Surgical Instruments, Inc. 4,354
Millennium Avalign Technologies, Inc. 2,128
Surtex Surtex Instruments Ltd 1,318
Life Instruments Life Instrument Corp. 1,135
Innomed, Inc. Innomed, Inc. 1,017
Aesculap Aesculap AG 1,013
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 973
Elmed Elmed, Inc. 919
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 891
Boss Instruments Boss Instruments, Ltd. 799
gSource Gsource, LLC. 753
Sklar® Sklar Corporation 753

Showing 12 of 2,238. All products under Retractor

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