Bit, Surgical
Drill Bit 2.0mm (5/64'') x 128.0mm, Non-Sterile
6manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Jiangxi Vision Plus Medical Technology Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 6 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | GFG |
| Device type | Bit, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-23 |
| Record revised | 2022-01-17 (version 5) |
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 |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 6 |
| Sizes | Length 84 to 128 mm |
| Distribution end date | 2020-05-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0277082086S1 | Length 128.0 mm | In distribution |
| 0277082085S7 | Diameter: 2.0 Millimeter | In distribution |
| 0277082086S5 | Diameter: 2.4 Millimeter | In distribution |
| 0277082085S5 | Diameter: 2.8 Millimeter | In distribution |
| 4200355040 | Diameter: 4.0 Millimeter | In distribution |
| 0277082085S2 | Diameter: 2.8 Millimeter | In distribution |
| 0277082087S1 | Diameter: 3.2 Millimeter | In distribution |
| 0277082085S3 | Diameter: 1.6 Millimeter | In distribution |
| 4200355045 | Diameter: 4.5 Millimeter | In distribution |
| 4200355032 | Diameter: 3.2 Millimeter | In distribution |
| 4200355042 | Diameter: 4.2 Millimeter | In distribution |
| 0277082085S1 | Length 128.0 mm | In distribution |
| 0277082085S4 | Diameter: 2.0 Millimeter | In distribution |
| 0277082087S6 | Length 128.0 mm | In distribution |
| 0277082086 | Length 84.0 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 391 |
| IntelliSense Drill Technology | Mcginley Orthopaedic Innovations, Inc | 60 |
| Conmed | ConMed Corporation | 50 |
| Orthopediatrics Instrumentation | Orthopediatrics, Corp | 43 |
| Bit, Surgical | Stryker Sustainability Solutions | 42 |
| Medline Renewal | Medline Industries, Inc. | 32 |
| Infinity | ConMed Corporation | 26 |
| Pack Precision Allograft Cartilage Kit | Pioneer Surgical Technology, Inc. | 24 |
| Pack™ | Pioneer Surgical Technology, Inc. | 24 |
| Precision Allograft Cartilage Kit (Pack™) | Rti Surgical, Inc. | 24 |
| Made-To-Order | Tornier Inc. | 23 |
| OrthoPediatrics Cannulated Screw System | Orthopediatrics, Corp | 23 |
Showing 12 of 121. All products under Bit, Surgical
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.