Blazer: C VAS
Catalogue number BCN3120, listed by IZI Medical Products LLC, United States, under Spinal Channeling Instrument, Vertebroplasty. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
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 | IZI Medical Products LLC, United States |
|---|---|
| FDA product code | OCJ |
| Device type | Spinal Channeling Instrument, Vertebroplasty |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K070293 |
| Record published | 2021-05-14 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BCN3120 | 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 |
| Spinal Channeling Instrument, Vertebroplasty | Stryker GmbH | 3 |
| 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 |
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.