Sklar
Censitrac Ready Aufricht Glabellar Rasps 8 Inchesbkd
12manufacturers in China registered for this device type
69catalogue 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 | Sklar Corporation, United States |
|---|---|
| FDA product code | HTR |
| Device type | Rasp |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-05-01 |
| Record revised | 2022-06-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 97-1620 | In distribution | ||
| 40-9075 | In distribution | ||
| 40-9820 | In distribution | ||
| 97-1506 | In distribution | ||
| 40-9840 | In distribution | ||
| 55-7065 | In distribution | ||
| 40-9899 | In distribution | ||
| 55-7067 | 2 | In distribution | |
| 40-9836 | In distribution | ||
| 40-9082 | In distribution | ||
| 40-9812C | In distribution | ||
| 97-1521 | In distribution | ||
| 40-9092 | In distribution | ||
| 55-6965C | In distribution | ||
| 97-1640 | In distribution | ||
| 55-7067C | 2 | In distribution | |
| 40-9898 | In distribution | ||
| 40-9847 | In distribution | ||
| 40-9884 | In distribution | ||
| 40-9090 | In distribution | ||
| 40-9260 | In distribution | ||
| 40-9094 | In distribution | ||
| 40-9894 | In distribution | ||
| 40-9817 | In distribution | ||
| 55-7065C | In distribution | ||
| 97-1625 | In distribution | ||
| 97-1632 | In distribution | ||
| 97-1520 | In distribution | ||
| 55-6965 | In distribution | ||
| 40-9872 | In distribution | ||
| 40-9876 | In distribution | ||
| 40-9093 | In distribution | ||
| 40-9883 | In distribution | ||
| 55-5980 | In distribution | ||
| 40-9692 | In distribution | ||
| 40-9875 | In distribution | ||
| 40-9815 | In distribution | ||
| 97-1642 | In distribution | ||
| 40-9816 | In distribution | ||
| 40-9091 | In distribution | ||
| 97-1635 | In distribution | ||
| 97-1645 | In distribution | ||
| 40-9841C | In distribution | ||
| 40-9889 | In distribution | ||
| 40-9835 | In distribution | ||
| 40-9826 | In distribution | ||
| 40-9160 | In distribution | ||
| 40-9886 | In distribution | ||
| 40-9693 | In distribution | ||
| 40-9812 | In distribution | ||
| 40-9896 | In distribution | ||
| 55-4510 | In distribution | ||
| 40-9825 | In distribution | ||
| 97-1615 | In distribution | ||
| 40-9844 | In distribution | ||
| 40-9841 | In distribution | ||
| 97-1505 | In distribution | ||
| 40-9688 | In distribution | ||
| 40-9086 | In distribution | ||
| 40-9885 | In distribution | ||
| 40-9893 | In distribution | ||
| 40-9882 | In distribution | ||
| 40-9837 | In distribution | ||
| 40-9880 | In distribution | ||
| 40-9900 | In distribution | ||
| 40-9686 | In distribution | ||
| 40-9712 | In distribution | ||
| 40-9902 | In distribution | ||
| 40-9901 | 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.