Bone Cement Injection Gun
3 catalogue numbers from SD8103, listed by Shanghai KiNETIC Medical Co Ltd, China, under Dispenser, Cement. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Jiangsu Changmei Medtech Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
| Guangzhou Clean Medical Products Manufacturing Corp | Guangzhou | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Shanghai KiNETIC Medical Co Ltd, China |
|---|---|
| FDA product code | KIH |
| Device type | Dispenser, Cement |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4200 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-07-20 |
| Record revised | 2018-03-29 (version 2) |
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, manufacturing date |
| Storage | Storage environment temperature 18 to 25 °C; Storage environment humidity up to 80 % RH |
| Sizes | Length 60 cm; pressure 440 psi |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SD8103 | Length 60 cm | In distribution |
| SD8101 | In distribution | |
| SD8102 | Length 60 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dispenser, Cement | Medtronic Sofamor Danek, Inc. | 14 |
| Pressurizer | Adler Ortho SpA | 11 |
| DJO Surgical | Encore Medical, L.P. | 7 |
| Vortex | Smith & Nephew, Inc. | 6 |
| Dispenser, Cement | Zimmer, Inc. | 5 |
| Miller™ | Zimmer, Inc. | 5 |
| Dispenser, Cement | Synthes (U.S.A.) LP | 5 |
| SpineJack | Stryker GmbH | 4 |
| Kyphon® Cement Delivery System | Medtronic Sofamor Danek, Inc. | 4 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 4 |
| PowerFlo | Zimmer, Inc. | 4 |
| Palamix® | Heraeus Medical LLC | 3 |
Showing 12 of 111. All products under Dispenser, Cement
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.