Spinal Channeling Instrument, Vertebroplasty
3 catalogue numbers from 0306813000, listed by Stryker GmbH, Switzerland, under Spinal Channeling Instrument, Vertebroplasty. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Beijing (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shanghai Lange Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 16 |
| Jiangsu Changmei Medtech Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
| Ningbo Hicren Biotechnology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 5 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | OCJ |
| Device type | Spinal Channeling Instrument, Vertebroplasty |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-04 |
| Record revised | 2022-12-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 6 |
| Sizes | Needle gauge 10 to 13 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0306813000 | Needle Gauge 13.0 G | In distribution |
| 0306620000 | Needle Gauge 10.0 G | In distribution |
| 0306621000 | Needle Gauge 11.0 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biopsybell | Biopsybell SRL | 25 |
| Biopsybell SRL | Biopsybell SRL | 9 |
| V-Access | G21 SRL | 6 |
| Capo Needle | Nexone BIO Co., Ltd. | 5 |
| Bone Drills | Shanghai Lange Medtech Co., Ltd. | 2 |
| KeyFix Direct Access Needle | G21 SRL | 2 |
| Kyphoplasty Tool Kit | Jiangsu Changmei Medtech Co., Ltd. | 2 |
| Kiva | Benvenue Medical, Inc. | 2 |
| Vertebroplasty needles | Teknimed SAS | 2 |
| Aliquot | Stryker GmbH | 2 |
| Blazer | Benvenue Medical, Inc. | 2 |
| Main-AXS Needle-Spinal Simplicity | Mainstream Medical Devices | 2 |
Showing 12 of 33. All products under Spinal Channeling Instrument, Vertebroplasty
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.