Osseous Burs-Course Diamond
Burs- Course Diamond are designed for giving the flexibility to treat a wide range of ENT conditions and anatomies from precise excision in delicate areas to rapid removal of large and…
Burs- Course Diamond are designed for giving the flexibility to treat a wide range of ENT conditions and anatomies from precise excision in delicate areas to rapid removal of large and bulky lesions.
5manufacturers in China registered for this device type
11catalogue 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 | EON Meditech PVT. Ltd., India |
|---|---|
| FDA product code | EQJ |
| Device type | Bur, Ear, Nose And Throat |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4140 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-07-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature up to 25 °C |
| Packaging | Laminated box of 10 |
| Sizes | Length 70 mm; outer diameter 0.5 to 6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EI2160CD | Length 70.0 mm | In distribution |
| EI2145CD | Length 70.0 mm | In distribution |
| EI2110CD | Length 70.0 mm | In distribution |
| EI2125CD | Length 70.0 mm | In distribution |
| EI2115CD | Length 70.0 mm | In distribution |
| EI2130CD | Length 70.0 mm | In distribution |
| EI2135CD | Length 70.0 mm | In distribution |
| EI2140CD | Length 70.0 mm | In distribution |
| EI2150CD | Length 70.0 mm | In distribution |
| EI2105CD | Length 70.0 mm | In distribution |
| EI2120CD | Length 70.0 mm | 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.