Panta®
The conical reamer of diameter 10.5 mm and of total length 350 mm for Panta® XL Nail is used to ream the intramedullary canal to prepare the nail insertion.
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 | Newdeal Sas, United States |
|---|---|
| FDA product code | HTW |
| Device type | Bit, Drill |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2017-05-26 |
| Record revised | 2023-10-04 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2027-04-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 539020ND | 10.5mm diam. x 60mm reaming part length | In distribution |
| 539022ND | 12.5mm diam. x 60mm reaming part length | In distribution |
| 519005ND | 5.0mm diam. x 66mm working length | In distribution |
| 519008ND | 4.3mm diam. x 204mm working length | In distribution |
| 519004ND | 4.3mm diam. x 177mm working length | In distribution |
| 519009ND | 9.0mm diam. x 104mm working length | In distribution |
| 519006ND | 4.3mm diam. x 181mm working length | In distribution |
| 539021ND | 11.5mm diam. x 60mm reaming part length | In distribution |
| 539023ND | 13.5mm diam. x 60mm reaming part length | In distribution |
| 519007ND | 7.0mm diam. x 100mm working length | In distribution |
| 519002ND | 4.3mm diam. x 204mm working length | In distribution |
| 519003ND | 4.3mm diam. x 181mm working length | In distribution |
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 |
| 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.