Biopsybell
Kyphoplasty Working Cannula AND Bevel/Trocar TIP
5manufacturers in China registered for this device type
25catalogue 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 | Biopsybell SRL |
|---|---|
| FDA product code | OCJ |
| Device type | Spinal Channeling Instrument, Vertebroplasty |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2020-06-12 |
| Record revised | 2022-10-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 5 to 40 °C |
| Packaging | Blister and pouch of 5, box of 5 |
| Sizes | Needle gauge 8 to 13 G; length 120 mm; length 15 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RENOVA SPINE KYPHOPLASTY TOOL KIT | Needle Gauge 10 G | In distribution |
| RENOVA SPINE KYPHOPLASTY BONE ACCESS NEEDLE | Needle Gauge 11 G | In distribution |
| CIFOPACK CLASSIC ACCESS SYSTEM | Needle Gauge 08 G | In distribution |
| KYPHOKIT FAST ACCESS SYSTEM | Needle Gauge 11 G | In distribution |
| RENOVA SPINE FAST ACCESS SYSTEM | Needle Gauge 11 G | In distribution |
| CIFOPACK WORKING CANNULA AND TROCAR TIP | Needle Gauge 13 G | In distribution |
| CIFOPACK WORKING CANNULA AND BEVEL TIP | Needle Gauge 11 G | In distribution |
| CIFOPACK BONE ACCESS NEEDLE | Needle Gauge 11 G | In distribution |
| KYPHOKIT CLASSIC ACCESS SYSTEM | Needle Gauge 08 G | In distribution |
| CIFOPACK FAST ACCESS SYSTEM | Needle Gauge 11 G | In distribution |
| KYPHOKIT WORKING CANNULA AND BEVEL TIP | Needle Gauge 11 G | In distribution |
| RENOVA SPINE WORKING CANNULA AND DIAMOND TIP | Needle Gauge 11 G | In distribution |
| RENOVA SPINE CLASSIC ACCESS SYSTEM | Needle Gauge 08 G | In distribution |
| RENOVA SPINE KYPHOPLASTY TOOL KIT | Needle Gauge 10 G | In distribution |
| KYPHOKIT WORKING CANNULA AND BEVEL/TROCAR TIP | Needle Gauge 11 G | In distribution |
| RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP | Needle Gauge 08 G | In distribution |
| RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL TIP | Needle Gauge 10 G | In distribution |
| RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND EXPANDER | Needle Gauge 08 G | In distribution |
| RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL TIP | Needle Gauge 08 G | In distribution |
| KYPHOKIT WORKING CANNULA AND TROCAR TIP | Needle Gauge 11 G | In distribution |
| CIFOPACK WORKING CANNULA AND DIAMOND TIP | Needle Gauge 08 G | In distribution |
| RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP | Needle Gauge 10 G | In distribution |
| KYPHOKIT WORKING CANNULA AND EXPANDER | Needle Gauge 08 G | In distribution |
| KYPHOKIT BONE ACCESS NEEDLE | Needle Gauge 11 G | In distribution |
| KYPHOKIT WORKING CANNULA AND DIAMOND TIP | Needle Gauge 11 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.