Bit, Drill
Drill, Ø5.0, cannulated, I-Ø2.6, L 250, Hudson coupling, Single Use
27manufacturers in China registered for this device type
114catalogue numbers in this listing
2recalls on this code
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.
| 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
| Listed by | AAP Implantate AG, Germany |
|---|---|
| FDA product code | HTW |
| Device type | Bit, Drill |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-02-28 |
| Record revised | 2022-11-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2025-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IU 7030-13-1U | In distribution | |
| IU 7030-13 | In distribution | |
| IU 7445-00-1U | In distribution | |
| IU 7035-13 | In distribution | |
| IU 7020-13 | In distribution | |
| IU 7425-18 | In distribution | |
| IU 7045-13-1U | In distribution | |
| IU 7427-20 | In distribution | |
| IU 7420-15 | In distribution | |
| IU 7420-11-1U | In distribution | |
| IU 7520-00 | In distribution | |
| IU 7420-18-1U | In distribution | |
| IU 7025-13 | In distribution | |
| IU 7432-33-1U | In distribution | |
| IU 7427-00 | In distribution | |
| IU 7017-05 | In distribution | |
| IU 7350-22-1U | In distribution | |
| IU 7420-16 | In distribution | |
| IU 7125-14 | In distribution | |
| IU 7420-11 | In distribution | |
| IU 7040-13-1U | In distribution | |
| IU 7423-18-1U | In distribution | |
| IU 7427-20-1U | In distribution | |
| IU 7425-00 | In distribution | |
| IU 7027-13 | In distribution | |
| IU 7344-22-1U | In distribution | |
| IU 7427-23-1U | In distribution | |
| IU 7125-14-1U | In distribution | |
| IU 7025-13-1U | In distribution | |
| IU 7120-13-1U | In distribution | |
| IU 7343-22 | In distribution | |
| IU 7017-05-1U | In distribution | |
| IU 7427-22 | In distribution | |
| IU 7335-12-1U | In distribution | |
| IU 7432-30-1U | In distribution | |
| IU 7420-10-1U | In distribution | |
| IU 7075-22-1U | In distribution | |
| IU 7035-13-1U | In distribution | |
| IU 7327-12-1U | In distribution | |
| IU 7438-22-1U | In distribution | |
| IU 7432-30 | In distribution | |
| IU 7344-22 | In distribution | |
| IU 7525-00 | In distribution | |
| IU 7435-00-1U | In distribution | |
| IU 7420-13 | In distribution | |
| IU 7427-15-1U | In distribution | |
| IU 7420-18 | In distribution | |
| IU 7343-22-1U | In distribution | |
| IU 7020-05 | In distribution | |
| IU 7438-33-1U | In distribution | |
| IU 7017-13 | In distribution | |
| IU 7150-25 | In distribution | |
| IU 7438-18-1U | In distribution | |
| IU 7423-18 | In distribution | |
| IU 7438-25-1U | In distribution | |
| IU 7438-22 | In distribution | |
| IU 7438-25 | In distribution | |
| IU 7438-20-1U | In distribution | |
| IU 7438-20 | In distribution | |
| IU 7335-12 | In distribution | |
| IU 7327-12 | In distribution | |
| IU 7432-00 | In distribution | |
| IU 7120-13 | In distribution | |
| IU 7411-00 | In distribution | |
| IU 7420-10 | In distribution | |
| IU 7535-00 | In distribution | |
| IU 7420-16-1U | In distribution | |
| IU 7415-00 | In distribution | |
| IU 7427-22-1U | In distribution | |
| IU 7065-22-1U | In distribution | |
| IU 7150-25-1U | In distribution | |
| IU 7425-00-1U | In distribution | |
| IU 7330-14-1U | In distribution | |
| IU 7040-13 | In distribution | |
| IU 7325-13-1U | In distribution | |
| IU 7045-13 | In distribution | |
| IU 7427-15 | In distribution | |
| IU 7325-13 | In distribution | |
| IU 7438-18 | In distribution | |
| IU 7427-16 | In distribution | |
| IU 7020-05-1U | In distribution | |
| IU 7427-23 | In distribution | |
| IU 7420-13-1U | In distribution | |
| IU 7435-00 | In distribution | |
| IU 7027-13-1U | In distribution | |
| IU 7432-33 | In distribution | |
| IU 7420-00 | In distribution | |
| IU 7350-22 | In distribution | |
| IU 7427-16-1U | In distribution | |
| IU 7137-21-1U | In distribution | |
| IU 7137-21 | In distribution | |
| IU 7445-00 | In distribution | |
| IU 7330-14 | In distribution | |
| IU 7438-33 | In distribution | |
| IU 7425-18-1U | Withdrawn | |
| 430404 | Withdrawn | |
| IU 7427-00-1U | Withdrawn | |
| IU 7420-00-1U | Withdrawn | |
| IU 7020-13-1U | Withdrawn | |
| IU 7432-00-1U | Withdrawn | |
| 10-017 | Withdrawn | |
| 430453 | Withdrawn | |
| IU 7058-22-1U | Withdrawn | |
| 430425 | Withdrawn | |
| IU 7525-00-1U | Withdrawn | |
| 430654 | Withdrawn | |
| IU 7535-00-1U | Withdrawn | |
| IU 7017-13-1U | Withdrawn | |
| 430755 | Withdrawn | |
| 430455 | Withdrawn | |
| IU 7415-00-1U | Withdrawn | |
| IU 7411-00-1U | Withdrawn | |
| 10-016 | Withdrawn | |
| IU 7420-15-1U | Withdrawn |
Same 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 |
| Emerge Medical & Design | Emerge Technologies, Inc. | 110 |
| Aptus | Medartis Inc. | 110 |
Showing 12 of 1,958. All products under Bit, Drill
Recalls
2 of these are Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-01-25 | Class III | Other | Products were distributed with the incorrect instructions for use. | 2 units | 2024-09-30 |
| 2019-01-25 | Class III | Other | Products were distributed with the incorrect instructions for use. | 7 units | 2024-09-30 |
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.