Gsource
gRasp, 15 1/2", Single-Sided, Straight, 12mm x 20mm, with Silicone Handle, Black, Threaded
12manufacturers in China registered for this device type
34catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Guangdong (3), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
Record
| Listed by | Gsource, LLC., United States |
|---|---|
| FDA product code | HTR |
| Device type | Rasp |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-03-12 |
| Record revised | 2022-08-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| gS 62.7540 | In distribution | |
| gS 61.6846 | In distribution | |
| gS 62.1660 | In distribution | |
| gS 62.8050 | In distribution | |
| gS 61.6725 | In distribution | |
| gS 61.6848 | In distribution | |
| gS 62.1520 | In distribution | |
| gS 61.6477 | In distribution | |
| gS 62.1670 | In distribution | |
| gS 62.6400 | In distribution | |
| gS 62.8100 | In distribution | |
| gS 61.6845 | In distribution | |
| gS 62.7550 | In distribution | |
| gS 62.9910 | In distribution | |
| gS 61.6843 | In distribution | |
| gS 62.7500 | In distribution | |
| gS 62.7720 | In distribution | |
| gS 61.6844 | In distribution | |
| gS 62.7548 | In distribution | |
| gS 62.1500 | In distribution | |
| gS 26.3070 | In distribution | |
| BR.62.6398 | In distribution | |
| gS 62.6398 | In distribution | |
| gS 61.6847 | In distribution | |
| gS 61.6841 | In distribution | |
| gS 62.1710 | In distribution | |
| gS 62.8101 | In distribution | |
| gS 61.6726 | In distribution | |
| gS 62.7680 | In distribution | |
| gS 61.6855 | In distribution | |
| gS 26.2380 | In distribution | |
| gS 62.8200 | In distribution | |
| gS 61.6842 | In distribution | |
| gS 62.7520 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 240 |
| TiWAVE C Cervical Cage System | Kalitec Direct, LLC | 232 |
| Tranquil-C™ | Nexus Spine, L.L.C. | 158 |
| Calix Spinal Implant System | Xtant Medical Holdings, Inc. | 143 |
| Rasp | Medtronic Sofamor Danek, Inc. | 109 |
| Specials | Seaspine Orthopedics Corporation | 109 |
| Stryker | Avalign Technologies, Inc. | 105 |
| Endoskeleton® TAS | Medtronic Sofamor Danek, Inc. | 93 |
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 90 |
| Cambria | Seaspine Orthopedics Corporation | 85 |
| IdentiTi | Alphatec Spine, Inc. | 83 |
| Link Instruments – Rasps, compressors and broaches | Waldemar Link GmbH & Co. KG | 83 |
Showing 12 of 378. All products under Rasp
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.