Stainless Steel Guide Wires

2.0/2.8mm x 110 SS Wire 20mm Partial Thread

Registry build 21.09.26
10manufacturers in China registered for this device type
76catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (4), Zhejiang (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KIJ
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
Shaanxi Ansen Medical Technology Development Co., Ltd. Xi’An Shaanxi Contract manufacturer 7
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Jiangsu Saikang Medical Equipment Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 34
Jiangsu Yongfa Medical Equipment Technology Co., Ltd. Zhangjiagang Jiangsu Manufacturer 33
Shanghai NO. 2 Medical College Duhang Medical Equipment Factory Shanghai Shanghai Contract manufacturer 32
Denjoy Dental Co., Ltd. Changsha Hunan Contract manufacturer 17
Gavin Biotechnology Co., Ltd. Jinzhong Shanxi Manufacturer 16
Suzhou Number WIN Medical Technology Co., Ltd. Zhangjiagang Jiangsu Manufacturer 16

Record

Regulatory record for Stainless Steel Guide Wires
Listed by Orthopediatrics, Corp, United States
FDA product code KIJ
Device type Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Device class Class 1
Regulation 21 CFR 878.4820
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-01-16
Record revised 2024-09-11 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Stainless Steel Guide Wires
Catalogue number Size Status
01-9473-7145 In distribution
01-9473-2112 In distribution
01-9473-0040 In distribution
01-9473-6115 In distribution
01-9473-0115 In distribution
01-9473-5010 In distribution
01-9473-6110 In distribution
01-9473-1010 In distribution
01-9473-5123 In distribution
01-9473-8020 In distribution
01-9473-9220 In distribution
01-9473-4020 In distribution
01-9473-8037 In distribution
01-9473-6330 In distribution
01-9473-0030 In distribution
01-9473-6120 In distribution
01-9473-7020 In distribution
01-9473-0108 In distribution
01-9473-6015 In distribution
01-9473-9225 In distribution
01-9473-7030 In distribution
01-9473-5007 In distribution
01-9473-5015 In distribution
01-9473-4015 In distribution
01-9473-0008 In distribution
01-9473-4120 In distribution
01-9473-5325 In distribution
01-9473-5310 In distribution
01-9473-0025 In distribution
01-9473-4007 In distribution
01-9473-9235 In distribution
01-9473-5315 In distribution
01-9473-4010 In distribution
01-9473-0035 In distribution
01-9473-5145 In distribution
01-9473-0130 In distribution
01-9473-4115 In distribution
01-9473-6007 In distribution
01-9473-6315 In distribution
01-9473-5330 In distribution
01-9473-7120 In distribution
01-9473-6107 In distribution
01-9473-9030 In distribution
01-9473-7140 In distribution
01-9473-5320 In distribution
01-9473-0125 In distribution
01-9473-6320 In distribution
01-9473-1110 In distribution
01-9473-6310 In distribution
01-9473-2012 In distribution
01-9473-0135 In distribution
01-9473-4107 In distribution
01-9473-5110 In distribution
01-9473-0015 In distribution
01-9473-7150 In distribution
01-9473-6020 In distribution
01-9473-4123 In distribution
01-9473-6325 In distribution
01-9473-5107 In distribution
01-9473-7130 In distribution
01-9473-9130 In distribution
01-9473-4110 In distribution
01-9473-8030 In distribution
01-9473-3015 In distribution
01-9473-9137 In distribution
01-9473-9180 In distribution
01-9473-5115 In distribution
01-9473-0140 In distribution
01-9473-8120 In distribution
01-9473-6010 In distribution
01-9473-5023 In distribution
01-9473-4023 In distribution
01-9473-9230 In distribution
01-9473-8130 In distribution
01-9473-9015 In distribution
01-9473-3115 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
OsteoMed Osteomed 36
CS2 Acetabular System Shalby Advanced Technologies, Inc. 32
Medinaut MAX Imedicom Co., Ltd. 25
MicroAire® Microaire Surgical Instruments LLC 20
R&D Batteries, Inc. R & D Batteries, Inc. 18
Pediatric Nailing Platform | Tibia Orthopediatrics, Corp 17
PNP Tibia Orthopediatrics, Corp 14
EZImpactor Imedicom Co., Ltd. 13
Insurgical, Inc. Insurgical, Inc. 12
Response Spine System Orthopediatrics, Corp 12
3P Hip System Orthopediatrics, Corp 12
Global Steptech Depuy (Ireland) 12

Showing 12 of 64. All products under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

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