Kmedic

Drill BIT Jacobs Chuck 5" 127 Millimeter 4.0 Millimeter Flute Length 35 Millimeter

Registry build 21.09.26
27manufacturers in China registered for this device type
42catalogue 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 Kmedic
Listed by Teleflex Medical LLC, United States
FDA product code HTW
Device type Bit, Drill
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2018-09-15
Record revised 2026-02-06 (version 4)

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, manufacturing date
Sizes Length 4.5 to 23 cm; outer diameter 1 to 6 mm; depth 1 to 6 mm
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Kmedic
Catalogue number Size Status
IPN014482 Length 12.7 cm In distribution
IPN014476 Length 12.7 cm In distribution
IPN014483 Length 12.7 cm In distribution
IPN014442 Length 11 cm In distribution
IPN014436 Length 8.5 cm In distribution
IPN014454 Length 9.5 cm In distribution
IPN014453 Length 13 cm In distribution
IPN014484 Length 12.7 cm In distribution
IPN014485 Length 12.7 cm In distribution
IPN014439 Length 10 cm In distribution
IPN014443 Length 14.5 cm In distribution
IPN014435 Depth 1.1 mm In distribution
IPN014480 Outer Diameter 3.2 mm In distribution
IPN014477 Outer Diameter 1.5 mm In distribution
IPN014455 Outer Diameter 3.5 mm In distribution
IPN014438 Depth 2.5 mm In distribution
IPN014450 Length 9.5 cm In distribution
IPN014456 Outer Diameter 4.5 mm In distribution
IPN014445 Depth 6 mm In distribution
IPN015710 Length 15.2 cm In distribution
IPN014446 Length 5.5 cm In distribution
IPN014444 Depth 4.5 mm In distribution
IPN014437 Depth 2 mm In distribution
IPN014479 Length 12.7 cm In distribution
IPN014448 Length 4.5 cm In distribution
IPN015714 Length 15.2 cm In distribution
IPN014475 Length 12.7 cm In distribution
IPN015715 Length 15 cm In distribution
IPN014395 Length 23 cm In distribution
IPN014440 Length 19.5 cm In distribution
IPN014452 Length 18 cm In distribution
IPN014441 Length 14.5 cm In distribution
IPN014457 Length 18 cm In distribution
IPN014434 Length 19.5 cm In distribution
IPN014449 Outer Diameter 2 mm In distribution
IPN014481 Outer Diameter 3.5 mm In distribution
IPN014447 Length 7 cm In distribution
IPN014451 Outer Diameter 2.7 mm In distribution
IPN015711 Length 15.2 cm In distribution
IPN015712 Length 15.2 cm In distribution
IPN014478 Outer Diameter 2.4 mm In distribution
IPN015713 Length 15.2 cm 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