Diego Elite
SHAVER BLADE, 4 MM, 40 DEGREES distal suction, T/A MALLEABLE, MONOPOLAR DIEGO ELITE
5manufacturers in China registered for this device type
97catalogue numbers in this listing
1recall
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 | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | EQJ |
| Device type | Bur, Ear, Nose And Throat |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4140 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-09-14 |
| Record revised | 2024-12-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SB4060RS | In distribution | |
| BUR4015DT | In distribution | |
| SB4040RS | In distribution | |
| MBUR4060DSC | In distribution | |
| MBUR1060FRCC | In distribution | |
| SB4090RS | In distribution | |
| LB2922SS | In distribution | |
| MBUR7060DVF | In distribution | |
| MBUR6060DVF | In distribution | |
| MBUR3075FRCV | In distribution | |
| SB2000SA | In distribution | |
| MBUR6060FRCV | In distribution | |
| MBUR5080DSC | In distribution | |
| MBUR2090DSF | In distribution | |
| MBUR4060DVF | In distribution | |
| LB2927SS | In distribution | |
| MBUR3060FRCV | In distribution | |
| MBUR2060DSF | In distribution | |
| MBUR6060DVC | In distribution | |
| STAPBUR17D | In distribution | |
| MBUR3060DVF | In distribution | |
| MS4000SS | In distribution | |
| SB4040SS | In distribution | |
| MBUR4060DVC | In distribution | |
| SB4000SC | In distribution | |
| MBUR1080DSF | In distribution | |
| MBUR3060FRCC | In distribution | |
| MBUR2075FRCV | In distribution | |
| MBUR6080DSC | In distribution | |
| BUR4070DT | In distribution | |
| BUR4260FB | In distribution | |
| MBUR2060FRCV | In distribution | |
| SB4075RC | In distribution | |
| MBUR1060FRCV | In distribution | |
| MBUR4080DSC | In distribution | |
| MBUR7080DSC | In distribution | |
| MBUR4060DSF | In distribution | |
| SB4800SC | In distribution | |
| MBUR3080FRCC | In distribution | |
| MBUR6060FRCC | In distribution | |
| SB4015SC | In distribution | |
| STAPBUR05D | In distribution | |
| SB4060SC | In distribution | |
| STAPBUR06D | In distribution | |
| MBUR2080DSF | In distribution | |
| MBUR5060DVF | In distribution | |
| MBUR2075DVF | In distribution | |
| MBUR1060DSF | In distribution | |
| SB4090RC | In distribution | |
| MBUR5060FRCV | In distribution | |
| MBUR7060FRCC | In distribution | |
| LB4022SD | In distribution | |
| MBUR1080FRCC | In distribution | |
| SB4000SS | In distribution | |
| SB4060RC | In distribution | |
| MBUR7060DSC | In distribution | |
| MBUR2080FRCC | In distribution | |
| MBUR1090DSF | In distribution | |
| MBUR7060DSF | In distribution | |
| BUR3070DB | In distribution | |
| MBUR3090DSF | In distribution | |
| MBUR5060DVC | In distribution | |
| STAPBUR07D | In distribution | |
| MBUR2060FRCC | In distribution | |
| SB2940SS | In distribution | |
| SB4015SS | In distribution | |
| SB2975SC | In distribution | |
| SB2975SS | In distribution | |
| MBUR6060DSF | In distribution | |
| MBUR4060FRCC | In distribution | |
| MBUR7060DVC | In distribution | |
| MBUR3075DVF | In distribution | |
| MBUR4060FRCV | In distribution | |
| SB4000SA | In distribution | |
| SB4060SS | In distribution | |
| STAPBUR10D | In distribution | |
| SB2900SC | In distribution | |
| STAPBUR08D | In distribution | |
| LB4027SD | In distribution | |
| STAPBUR20D | In distribution | |
| SB2900SS | In distribution | |
| SB4040RC | In distribution | |
| MBUR3080DSF | In distribution | |
| MBUR6060DSC | In distribution | |
| BUR4215FB | In distribution | |
| MBUR1060DVF | In distribution | |
| SB4040SC | In distribution | |
| MBUR1075DVF | In distribution | |
| MBUR1075FRCV | In distribution | |
| MBUR5060DSF | In distribution | |
| MBUR5060FRCC | In distribution | |
| MBUR2060DVF | In distribution | |
| MBUR3060DSF | In distribution | |
| MBUR7060FRCV | In distribution | |
| MBUR5060DSC | In distribution | |
| BUR4515BB | In distribution | |
| SB4800SA | 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 |
| 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 |
| Bur, Ear, Nose And Throat | Hager & Meisinger Gesellschaft mit beschränkter Haftung | 30 |
Showing 12 of 646. All products under Bur, Ear, Nose And Throat
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Reason | Quantity |
|---|---|---|---|---|---|
| Gyrus Acmi, Inc. | UDI-DI | 2017-08-03 | Class II | “Chattering” when cutting burrs are used in bone. | 324 |
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.