Bur, Ear, Nose and Throat
Rotary instrument for ENT surgery
5manufacturers in China registered for this device type
30catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (1), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Zonefly Medical Devices Co., Ltd. | Danyang | Jiangsu | Specification developer | 7 |
| Guizhou Zirui Technology Co., Ltd. | Tongzi County, Zunyi | Guizhou | Manufacturer | 4 |
Record
| Listed by | Hager & Meisinger Gesellschaft mit beschränkter Haftung |
|---|---|
| FDA product code | EQJ |
| Device type | Bur, Ear, Nose And Throat |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4140 |
| Premarket notification | Exempt |
| Record published | 2021-09-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 242 060 | In distribution | |
| 242 023 | In distribution | |
| LH242 008 | In distribution | |
| LH242 007 | In distribution | |
| LH242 027 | In distribution | |
| LH242 035 | In distribution | |
| 242 070 | In distribution | |
| 242 015 | In distribution | |
| 242 031 | In distribution | |
| LH242 023 | In distribution | |
| LH242 006 | In distribution | |
| 242 010 | In distribution | |
| 242 025 | In distribution | |
| 242 008 | In distribution | |
| LH242 050 | In distribution | |
| 242 050 | In distribution | |
| 242 030 | In distribution | |
| LH242 031 | In distribution | |
| 242 035 | In distribution | |
| 242 007 | In distribution | |
| LH242 010 | In distribution | |
| LH242 070 | In distribution | |
| 242 018 | In distribution | |
| LH242 014 | In distribution | |
| 242 020 | In distribution | |
| 242 040 | In distribution | |
| LH242 018 | In distribution | |
| LH242 045 | In distribution | |
| LH242 040 | In distribution | |
| 242 027 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bur, Ear, Nose And Throat | Medtronic Xomed, Inc. | 413 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 99 |
| Diego Elite | Gyrus Acmi, Inc. | 97 |
| Jedmed | Jedmed Instrument Company | 88 |
| Diego | Gyrus Acmi, Inc. | 56 |
| RAD® | Medtronic Xomed, Inc. | 53 |
| Invotec ENT Bur | Invotec International, Inc. | 50 |
| NSK Sterile Burs/Drills | Nakanishi Inc. | 46 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 41 |
| Bur, Ear, Nose And Throat | Karl Storz GmbH & Co. KG | 39 |
| Medline | Medline Industries, Inc. | 36 |
| Tricut® | Medtronic Xomed, Inc. | 31 |
Showing 12 of 646. All products under Bur, Ear, Nose And Throat
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.