IdentiTi
Double-sided 16mm Wide Straight Rasp - 4.5mm Tall
12manufacturers in China registered for this device type
83catalogue 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 | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | HTR |
| Device type | Rasp |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-03-18 |
| Record revised | 2022-06-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Width 18 to 22 mm; height 4 to 16 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 113-111-14186000 | Width 18 mm | In distribution |
| 113-110-04226000 | Height 4 mm | In distribution |
| 168-16-201-12 | In distribution | |
| 168-16-101-10 | In distribution | |
| 113-87 | In distribution | |
| 168-16-001-10 | In distribution | |
| 113-111-09226000 | Width 22 mm | In distribution |
| 113-111-14226000 | Height 14 mm | In distribution |
| 113-110-05226000 | Width 22 mm | In distribution |
| 113-110-08226000 | Width 22 mm | In distribution |
| 113-111-05186000 | Height 5 mm | In distribution |
| 113-111-16186000 | Height 16 mm | In distribution |
| 113-111-06226000 | Width 22 mm | In distribution |
| 113-85 | In distribution | |
| 113-111-07226000 | Height 7 mm | In distribution |
| 113-111-10186000 | Height 10 mm | In distribution |
| 113-110-16226000 | Width 22 mm | In distribution |
| 113-110-05186000 | Width 18 mm | In distribution |
| 113-111-06186000 | Height 6 mm | In distribution |
| 113-111-13226000 | Height 13 mm | In distribution |
| 113-110-15186000 | Height 15 mm | In distribution |
| 113-110-10186000 | Width 18 mm | In distribution |
| 168-16-101-20 | In distribution | |
| 113-111-12226000 | Height 12 mm | In distribution |
| 168-16-101-14 | In distribution | |
| 113-111-05226000 | Width 22 mm | In distribution |
| 168-16-101-18 | In distribution | |
| 168-16-001-18 | In distribution | |
| 113-110-15226000 | Width 22 mm | In distribution |
| 113-111-16226000 | Height 16 mm | In distribution |
| 113-110-14186000 | Height 14 mm | In distribution |
| 168-16-201-14 | In distribution | |
| 168-16-201-16 | In distribution | |
| 113-111-09186000 | Height 9 mm | In distribution |
| 113-110-08186000 | Height 8 mm | In distribution |
| 168-16-101-16 | In distribution | |
| 168-16-101-24 | In distribution | |
| 113-111-10226000 | Height 10 mm | In distribution |
| 113-110-09226000 | Height 9 mm | In distribution |
| 168-16-201-24 | In distribution | |
| 168-16-001-14 | In distribution | |
| 113-110-07186000 | Height 7 mm | In distribution |
| 113-110-16186000 | Width 18 mm | In distribution |
| 113-111-15186000 | Width 18 mm | In distribution |
| 113-111-12186000 | Height 12 mm | In distribution |
| 113-111-11186000 | Height 11 mm | In distribution |
| 113-110-10226000 | Height 10 mm | In distribution |
| 113-110-14226000 | Width 22 mm | In distribution |
| 113-110-12186000 | Height 12 mm | In distribution |
| 113-110-13226000 | Width 22 mm | In distribution |
| 168-16-001-22 | In distribution | |
| 113-110-13186000 | Width 18 mm | In distribution |
| 130-020 | In distribution | |
| 113-110-12226000 | Width 22 mm | In distribution |
| 113-111-04226000 | Width 22 mm | In distribution |
| 113-110-04186000 | Height 4 mm | In distribution |
| 113-110-06186000 | Width 18 mm | In distribution |
| 113-110-06226000 | Width 22 mm | In distribution |
| 113-110-11186000 | Height 11 mm | In distribution |
| CI-10097-02 | In distribution | |
| 168-16-001-24 | In distribution | |
| 168-16-201-22 | In distribution | |
| 113-110-07226000 | Height 7 mm | In distribution |
| 168-16-201-18 | In distribution | |
| 168-16-201-20 | In distribution | |
| 168-16-001-20 | In distribution | |
| 168-16-101-12 | In distribution | |
| 168-16-001-12 | In distribution | |
| 127-200 | In distribution | |
| 113-111-08186000 | Height 8 mm | In distribution |
| 113-111-07186000 | Height 7 mm | In distribution |
| 168-16-101-22 | In distribution | |
| 113-111-11226000 | Width 22 mm | In distribution |
| 113-111-08226000 | Height 8 mm | In distribution |
| 113-111-04186000 | Width 18 mm | In distribution |
| 168-16-201-10 | In distribution | |
| 113-110-09186000 | Width 18 mm | In distribution |
| CI-10097-01 | In distribution | |
| 168-16-001-16 | In distribution | |
| 113-111-13186000 | Height 13 mm | In distribution |
| 113-111-15226000 | Width 22 mm | In distribution |
| 113-86 | In distribution | |
| 113-110-11226000 | Width 22 mm | 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 |
| Link Instruments – Rasps, compressors and broaches | Waldemar Link GmbH & Co. KG | 83 |
| Rasp | Zimmer, Inc. | 77 |
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.