Surgical Direct

5 3/4" Bunnel Drill, Canulated 3 Jaw Stainless Steel Chuck, Accepts Wires & Pins Up to 5/32" (4.0mm)

Registry build 21.09.26
27manufacturers in China registered for this device type
40catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (12), Shanghai (5), Guangdong (4). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HTW
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Turnxon Precision Co., Ltd. Dongguan Guangdong Contract manufacturer 17
Autocam Medical Devices (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 9
Aplus (Guangzhou) Medical Technology Company Guangzhou Guangdong Contract manufacturer 6
Changzhou Wastonortho Medical Appliance Co., Ltd. Changzhou Jiangsu Contract manufacturer 5

Showing 12 of 27. All 27 manufacturers in China registered for Bit, Drill

Record

Regulatory record for Surgical Direct
Listed by Surgical Direct, Inc., United States
FDA product code HTW
Device type Bit, Drill
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2022-12-03
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
SDM16910 In distribution
SDM16908 In distribution
SDM169590 In distribution
SDM17006 In distribution
SDM16962 In distribution
SDM16915 In distribution
SDM17003 In distribution
SDM17004 In distribution
SDM16902 In distribution
SD91409800 In distribution
SDM16901 In distribution
SD91410620 In distribution
SDM172150 In distribution
SDM17010 In distribution
SDM17002 In distribution
SDM17007 In distribution
SDM16961 In distribution
SDM16912 In distribution
SDM16904 In distribution
SDM16914 In distribution
SDM16963 In distribution
SD14103-1001 In distribution
SDM17005 In distribution
SDM169620 In distribution
SDM16922 In distribution
SDM16906 In distribution
SD91410400 In distribution
SDM17011 In distribution
SDM16913 In distribution
SDM16905 In distribution
SD914096100 In distribution
SD14094-000 In distribution
SDM16959 In distribution
SDM16919 In distribution
SDM16903 In distribution
SDM17055 In distribution
SDM16916 In distribution
SDM16960 In distribution
SD2960-0000 In distribution
SDM16920 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Bit, Drill Sterilmed, Inc. 633
Bit, Drill Synthes Gmbh 412
Arthrex® Arthrex, Inc. 406
Level ONE KLS-Martin L.P. 246
Acumed Acumed LLC 205
Stryker Provision 198
Arthrex Provision 186
Tecomet Tecomet, Inc. 166
Synthes Provision 164
Drill bit Jeil Medical Corporation 134
Bit, Drill AAP Implantate AG 114
Emerge Medical & Design Emerge Technologies, Inc. 110

Showing 12 of 1,958. All products under Bit, Drill

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