Mini-Bolt System
Stryker Precision Targeting System - 4.5mm Drill Guide, Packaged
4manufacturers in China registered for this device type
41catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Hotry Co., Ltd. | Beijing | Beijing | Manufacturer | 9 |
Record
| Listed by | Monteris Medical Corp, United States |
|---|---|
| FDA product code | HAO |
| Device type | Instrument, Surgical, Non-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4535 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-14 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep Away from Sunlight |
| Sizes | Lumen/inner diameter 1.6 to 7.5 mm; outer diameter 1.6 to 25.36 mm; length 9 to 457.2 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20802 | Lumen/Inner Diameter 7.5 mm | In distribution |
| 20819 | Outer Diameter 4.4 mm | In distribution |
| 20784 | Outer Diameter 3.4 mm | In distribution |
| 21228 | Lumen/Inner Diameter 6 mm | In distribution |
| 21209 | Outer Diameter 1.6 mm | In distribution |
| 20811 | Outer Diameter 3.3 mm | In distribution |
| 21247 | Lumen/Inner Diameter 4.5 mm | In distribution |
| 20755 | Lumen/Inner Diameter 2.2 mm | In distribution |
| 20818 | Outer Diameter 5 mm | In distribution |
| 20815 | Outer Diameter 2.2 mm | In distribution |
| 20820 | Lumen/Inner Diameter 5 mm | In distribution |
| 20722 | Lumen/Inner Diameter 4.5 mm | In distribution |
| 20677 | Outer Diameter 2.2 mm | In distribution |
| 20754 | Lumen/Inner Diameter 3.3 mm | In distribution |
| 20812 | Lumen/Inner Diameter 3.3 mm | In distribution |
| 21239 | Lumen/Inner Diameter 3.3 mm | In distribution |
| 20739 | Outer Diameter 19.95 mm | In distribution |
| 20817 | Lumen/Inner Diameter 2.2 mm | In distribution |
| 22004 | Outer Diameter 1.6 mm | In distribution |
| 29008 | Outer Diameter 1.6 mm | In distribution |
| 21224 | Outer Diameter 1.6 mm | In distribution |
| 21154 | Lumen/Inner Diameter 2.2 mm | In distribution |
| 21153 | Lumen/Inner Diameter 3.3 mm | In distribution |
| 20637 | Outer Diameter 3.3 mm | In distribution |
| 20810 | Lumen/Inner Diameter 4.5 mm | In distribution |
| 21155 | Lumen/Inner Diameter 6 mm | In distribution |
| 20659 | Lumen/Inner Diameter 2.2 mm | In distribution |
| 20628 | Lumen/Inner Diameter 3.3 mm | In distribution |
| 20626 | Outer Diameter 25.36 mm | In distribution |
| 21061 | Outer Diameter 10 mm | In distribution |
| 20814 | Lumen/Inner Diameter 2.2 mm | In distribution |
| 20693 | Lumen/Inner Diameter 2.2 mm | In distribution |
| 20627 | Outer Diameter 17.97 mm | In distribution |
| 21165 | Lumen/Inner Diameter 1.6 mm | In distribution |
| 20813 | Lumen/Inner Diameter 4.5 mm | In distribution |
| 21065 | Lumen/Inner Diameter 4.5 mm | In distribution |
| 20821 | Length 9 mm | In distribution |
| 21237 | Lumen/Inner Diameter 2.2 mm | In distribution |
| 20816 | Outer Diameter 3.3 mm | In distribution |
| 20725 | Length 457.2 mm | In distribution |
| 20694 | Lumen/Inner Diameter 3.3 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 705 |
| Ambler Surgical | Ambler Surgical, LLC | 597 |
| V. Mueller | Steris Corporation | 577 |
| Millennium | Avalign Technologies, Inc. | 383 |
| Avalign | Avalign Technologies, Inc. | 352 |
| Novo Surgical | Novo Surgical, Inc. | 300 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 283 |
| Boss Instruments | Boss Instruments, Ltd. | 263 |
| Pilling | Teleflex Medical LLC | 156 |
| Instrument, Surgical, Non-Powered | Karl Storz GmbH & Co. KG | 130 |
| Instrument, Surgical, Non-Powered | Fehling Instruments GmbH | 126 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 109 |
Showing 12 of 249. All products under Instrument, Surgical, Non-Powered
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.