Surgical Direct

5 1/8" Castroviejo Blade Breaker and Holder, 12.0mm Smooth Jaws, Round Knurled Handle, with Push-Pull End Lock

Registry build 21.09.26
29manufacturers in China registered for this device type
68catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (9), Shanghai (9), Zhejiang (3). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GDZ
Manufacturer City Province Registered as Device types
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Malosa Medical Instruments (Changshu) Limited Changshu Jiangsu Contract manufacturer 24
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
Xiantao Sanda Industrial Co., Ltd. Xiantao Hubei Contract manufacturer 10
Ningbo Medsun Medical Co., Ltd. Ningbo Zhejiang Contract manufacturer 7
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Shanghai NEO-Medical Import & Export Co., Ltd. Shanghai Shanghai Exporter 59

Showing 12 of 29. All 29 manufacturers in China registered for Handle, Scalpel

Record

Regulatory record for Surgical Direct
Listed by Surgical Direct, Inc., United States
FDA product code GDZ
Device type Handle, Scalpel
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2022-12-02
Record revised 2024-04-17 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for Surgical Direct
Catalogue number Size Status
SD904066102 In distribution
SD904066104 In distribution
SD904031100 In distribution
SD90406569 In distribution
SD904065101 In distribution
SD90401004 In distribution
SD90406525 In distribution
SD90432020 In distribution
SD904555100 In distribution
SD904066-1000 In distribution
SD90402015 In distribution
SD90406567 In distribution
SD904555102 In distribution
SD902046101 In distribution
SD90432021 In distribution
SD90401003 In distribution
SD90406513 In distribution
SD91321530 In distribution
SD904066104E In distribution
SD90455510 In distribution
SD90430028 In distribution
SD904066107 In distribution
SD90403016 In distribution
SD91401035 In distribution
SD90402014 In distribution
SD91479320 In distribution
SD902046100 In distribution
SD90402013 In distribution
SD90406510 In distribution
SD904043101 In distribution
SD91321520 In distribution
SD90406515 In distribution
SD904020101 In distribution
SD90402030 In distribution
SD90402523 In distribution
SD90406511 In distribution
SD90423010 In distribution
SD90430022 In distribution
SD90406710 In distribution
SD904200100 In distribution
SD934317-1000 In distribution
SD90400903 In distribution
SD90401003LH In distribution
SD90402707 In distribution
SD4044-1020 In distribution
SD90402045 In distribution
SD90404209 In distribution
SD904555103 In distribution
SD93431710 In distribution
SD90402507 In distribution
SD90404310 In distribution
SD904555101 In distribution
SD90455413 In distribution
SD48-1128 In distribution
SD4044-1021 In distribution
SD904021140 In distribution
SD90406564 In distribution
SD904066101 In distribution
SD90401003E In distribution
SD904020100 In distribution
SD904066108 In distribution
SD90432024 In distribution
SD91321518 In distribution
SD90430019 In distribution
SD90402035 In distribution
SD904200120 In distribution
SD904042100 In distribution
SD48-3601-01 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
comknife® Beijing Bohai Kangyuan Medical Devices Co., Ltd. 298
Millennium Avalign Technologies, Inc. 46
Aesculap Aesculap AG 41
Ambler Surgical Ambler Surgical, LLC 39
MSI Precision Specialty Instruments MED Saver, Inc. 37
DeRoyal Deroyal Industries, Inc. 34
Integra® Jarit® Integra LifeSciences Production Corporation 31
V. Mueller Steris Corporation 31
gSource Gsource, LLC. 29
Handle KLS-Martin L.P. 28
Sklar® Sklar Corporation 28
Integra® Miltex® Integra LifeSciences Production Corporation 27

Showing 12 of 226. All products under Handle, Scalpel

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