ACE

Needleholder Castroviejo STR Serrated Fine TC 5-1/2" 14CM TIP Less Than 1.5MM Wide

Registry build 21.09.26
15manufacturers in China registered for this device type
42catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (5), Zhejiang (3), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HXK
Manufacturer City Province Registered as Device types
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71
Anhui Medpurest Medical Technology Co., Ltd. Anqing Anhui Manufacturer 46
Anqing Kangmingna Packaging Co., Ltd. Anqing Anhui Contract manufacturer 39
Beijing Fule Science & Technology Development Co., Ltd. Beijing Beijing Manufacturer 31
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
Shanghai Reach Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 30
Ningbo Yingmed Medical Instruments Co., Ltd. Ningbo Zhejiang Manufacturer 29
Asol Co., Ltd. Huaian Jiangsu Manufacturer 22
Huaian Tisurg Medical Instruments Co., Ltd. Huaian Jiangsu Contract manufacturer 22

Showing 12 of 15. All 15 manufacturers in China registered for Holder, Needle; Orthopedic

Record

Regulatory record for ACE
Listed by Ace Surgical Supply Co., Inc., United States
FDA product code HXK
Device type Holder, Needle; Orthopedic
Device class Class 1
Regulation 21 CFR 888.4540
Premarket notification Exempt
Record published 2019-10-24
Record revised 2021-01-08 (version 2)

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
Storage Special storage condition: No special storage conditions required
Sizes Length 5.5 to 20 cm

Catalogue Numbers

Catalogue numbers for ACE
Catalogue number Size Status
3005154 Length 18 cm In distribution
3005103 Length 12 cm In distribution
00320118 In distribution
3000037 Length 14 cm In distribution
3001012 Length 15 cm In distribution
3105016 Length 18 cm In distribution
3005111 Length 20 cm In distribution
3105206 Length 14 cm In distribution
3005109 Length 16 cm In distribution
3005145 Length 15 cm In distribution
3005174 Length 14 cm In distribution
3105205 Length 14 cm In distribution
3105112 Length 14 cm In distribution
3105111 Length 14 cm In distribution
3000002 Length 13.5 cm In distribution
3015001 Length 13.5 cm In distribution
3105018 Length 18 cm In distribution
3001018 Length 15 cm In distribution
3001013 Length 18 cm In distribution
3005119 Length 20 cm In distribution
3005159 Length 15 cm In distribution
3005117 Length 15 cm In distribution
3002016 Length 15 cm In distribution
3005123 Length 15 cm In distribution
3005118 Length 18 cm In distribution
7713035 Length 13 cm In distribution
0033199 In distribution
3005153 Length 15 cm In distribution
3005107 Length 12 cm In distribution
3000006 Length 13 cm In distribution
3005149 Length 15 cm In distribution
3111003 Length 14 cm In distribution
3005110 Length 18 cm In distribution
3001019 Length 18 cm In distribution
3005102 Length 14 cm In distribution
0900107 Length 16.5 cm In distribution
3105110 Length 5.5 cm In distribution
3215010 Length 18 cm In distribution
3005100 Length 13 cm In distribution
3000003 Length 14.5 cm In distribution
3105010 Length 14 cm In distribution
3001020 Length 20 cm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sklar® Sklar Corporation 675
Needle Holder KLS-Martin L.P. 183
Anmuth Medical International Anmuth Medical International LLC 148
gSource Gsource, LLC. 147
BMT Medizintechnik GmbH BMT Medizintechnik GmbH 139
Orthomed Ortho-MED, Inc. 134
Holder, Needle; Orthopedic Fehling Instruments GmbH 119
Marina Medical Marina Medical Instruments, Inc. 115
Durogrip Aesculap AG 78
Stephens Instruments Krishna Imports Inc 77
Aesculap Aesculap AG 73
Diadust Aesculap AG 71

Showing 12 of 158. All products under Holder, Needle; Orthopedic

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