Bit, Drill

2.7 MM X 100.0 MM Stainless Steel Twist Drill BIT W/AO Quick Connect, 2 Flute

Registry build 21.09.26
27manufacturers in China registered for this device type
36catalogue 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 Bit, Drill
Listed by Omega Surgical Instruments, Inc., United States
FDA product code HTW
Device type Bit, Drill
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2022-05-31
Record revised 2022-05-20 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Radiation Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Bit, Drill
Catalogue number Size Status
OZD-624 In distribution
W1551N In distribution
OSD-826 In distribution
W1051 In distribution
OSD-8288 In distribution
OSD-819 In distribution
OZD-629 In distribution
OSD-844 In distribution
OZD-623 In distribution
OSD-835 In distribution
OZD-625 In distribution
OZD-622 In distribution
OLD-800004 In distribution
H-448 In distribution
OSD-811 In distribution
OZD-626 In distribution
H-447 In distribution
OZD-21200-02 In distribution
W1551 In distribution
HC-182 In distribution
OSD-825 In distribution
OSD-820 In distribution
H-449 In distribution
W2051N In distribution
OSD-831 In distribution
W2051 In distribution
W1051N In distribution
OSD-8510 In distribution
OZD-628 In distribution
OSD-824 In distribution
HC-181 In distribution
OZD-627 In distribution
OZD-621 In distribution
OSD-815 In distribution
L2070N In distribution
OSD-25170 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