ENT MR8
Attachment 1847ATTSS ENTMR8 Straight STD
2manufacturers in China registered for this device type
234catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
Record
| Listed by | Medtronic Powered Surgical Solutions, United States |
|---|---|
| FDA product code | ERL |
| Device type | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4250 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K183515 |
| Record published | 2020-10-02 |
| Record revised | 2022-09-16 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1847B50SDF | In distribution | ||
| 1847TRAY | In distribution | ||
| 1847B10LDC | In distribution | ||
| 1847ATTSS | In distribution | ||
| 1847B15SCF | In distribution | ||
| 1847B30SDF | In distribution | ||
| 1847B40SCT | In distribution | ||
| 1847ATTAV-R | In distribution | ||
| 1847B20LCT | In distribution | ||
| 1847B50SDC | In distribution | ||
| 1847B10LDC | In distribution | ||
| 1847B30LDC | In distribution | ||
| 1847B50SDX | In distribution | ||
| 1847B70SCT | In distribution | ||
| 1847B15SCT | In distribution | ||
| 1847B30LCF | In distribution | ||
| 1847B30LCT | In distribution | ||
| 1847CV15SCT | In distribution | ||
| 1847B15SDC | In distribution | ||
| 1847B10LCT | In distribution | ||
| 1847B40SDX | In distribution | ||
| 1847B10SDM | In distribution | ||
| 1847B05LCT | In distribution | ||
| 1847B40SDM | In distribution | ||
| 1847B60SCC | In distribution | ||
| 1847B20LDM | In distribution | ||
| 1847B10LCF | In distribution | ||
| 1847B15LCF | In distribution | ||
| 1847B20SDF | In distribution | ||
| 1847B70SDC | In distribution | ||
| 1847B25LDF | In distribution | ||
| 1847CV40SCT | In distribution | ||
| 1847B20SCT | In distribution | ||
| 1847B30LCT | In distribution | ||
| 1847B30SDF | In distribution | ||
| 1847B20LCF | In distribution | ||
| 1847B60SDM | In distribution | ||
| 1847B25SDF | In distribution | ||
| 1847CV40LDF | In distribution | ||
| 1847B20LCT | In distribution | ||
| 1847B25SCT | In distribution | ||
| 1847B50SDM | In distribution | ||
| 1847B60SDX | In distribution | ||
| 1847B60SDF | In distribution | ||
| 1847WRENCH | In distribution | ||
| 1847B35SDM | In distribution | ||
| 1847B25SCF | In distribution | ||
| 1847B40SDC | In distribution | ||
| 1847B15SDF | In distribution | ||
| 1847CV20LDF | In distribution | ||
| 1847CV12SDF | In distribution | ||
| 1847B20LDF | In distribution | ||
| 1847B10SDC | In distribution | ||
| 1847B60SCC | In distribution | ||
| 1847B70SCC | In distribution | ||
| 1847B10LCF | In distribution | ||
| 1847B15LDC | In distribution | ||
| 1847B25SDM | In distribution | ||
| 1847B40LDC | In distribution | ||
| 1847B20LDF | In distribution | ||
| 1847CV05SDF | In distribution | ||
| 1847CV20LDC | In distribution | ||
| 1847B35LCT | In distribution | ||
| 1847CV30SCT | In distribution | ||
| 1847BRACK | In distribution | ||
| 1847B15SCF | In distribution | ||
| 1847CV20SDF | In distribution | ||
| 1847B10LDM | In distribution | ||
| 1847CV40LCT | In distribution | ||
| 1847B50SCT | In distribution | ||
| 1847B40SCT | In distribution | ||
| 1847B80SCT | In distribution | ||
| 1847B35SCT | In distribution | ||
| 1847B20LCF | In distribution | ||
| 1847B06LDM | In distribution | ||
| 1847B20SDM | In distribution | ||
| 1847ATTAS-R | In distribution | ||
| 1847B35LDM | In distribution | ||
| 1847B10LDF | In distribution | ||
| 1847B08LDM | In distribution | ||
| 1847B25LDM | In distribution | ||
| 1847B25LDM | In distribution | ||
| 1847B70SDM | In distribution | ||
| 1847B30LDM | In distribution | ||
| 1847B30SDM | In distribution | ||
| 1847B60SCT | In distribution | ||
| 1847B60SCF | In distribution | ||
| 1847B10SCT | In distribution | ||
| 1847B30LCF | In distribution | ||
| 1847B10SDM | In distribution | ||
| 1847CV20LCT | In distribution | ||
| 1847B25LCT | In distribution | ||
| 1847DRLMTR-R | In distribution | ||
| 1847B50LDF | In distribution | ||
| 1847B50SDC | In distribution | ||
| 1847DRLMTR | In distribution | ||
| 1847B15SDM | In distribution | ||
| 1847B25SDF | In distribution | ||
| 1847B15SDC | In distribution | ||
| 1847B20SDC | In distribution | ||
| 1847CV20SCT | In distribution | ||
| 1847CV20LDF | In distribution | ||
| 1847B25LCF | In distribution | ||
| 1847CV30SDC | In distribution | ||
| 1847B08LDM | In distribution | ||
| 1847B15SDM | In distribution | ||
| 1847B50SDX | In distribution | ||
| 1847CV40LDC | In distribution | ||
| 1847B20SCT | In distribution | ||
| 1847B50SCF | In distribution | ||
| 1847B25LDF | In distribution | ||
| 1847B35LCF | In distribution | ||
| 1847B15LCT | In distribution | ||
| 1847B30SCC | In distribution | ||
| 1847B35SDM | In distribution | ||
| 1847BRUSH | 5 | In distribution | |
| 1847B12LDM | In distribution | ||
| 1847ATTAV | In distribution | ||
| 1847B10SCF | In distribution | ||
| 1847B40SCC | In distribution | ||
| 1847B40LDC | In distribution | ||
| 1847B20SDF | In distribution | ||
| 1847B10SDF | In distribution | ||
| 1847CV40SDC | In distribution | ||
| 1847B30SCF | In distribution | ||
| 1847B20LDC | In distribution | ||
| 1847B50SCT | In distribution | ||
| 1847B60SDC | In distribution | ||
| 1847B15LDF | In distribution | ||
| 1847B30LDC | In distribution | ||
| 1847ATTAS | In distribution | ||
| 1847CV10LDF | In distribution | ||
| 1847B25SDM | In distribution | ||
| 1847B50SCF | In distribution | ||
| 1847CV30SDF | In distribution | ||
| 1847B15SCT | In distribution | ||
| 1847B15LCF | In distribution | ||
| 1847CV10LDF | In distribution | ||
| 1847B25SDC | In distribution | ||
| 1847B30SCT | In distribution | ||
| 1847B20LDC | In distribution | ||
| 1847CV30LDF | In distribution | ||
| 1847B70SCT | In distribution | ||
| 1847B80SCT | In distribution | ||
| 1847CV10LCT | In distribution | ||
| 1847B35LCF | In distribution | ||
| 1847B50SDM | In distribution | ||
| 1847B25SDC | In distribution | ||
| 1847CV30LDF | In distribution | ||
| 1847B40LDM | In distribution | ||
| 1847B20SCF | In distribution | ||
| 1847B30SDC | In distribution | ||
| 1847CV30LDC | In distribution | ||
| 1847B25LCF | In distribution | ||
| 1847B15LDF | In distribution | ||
| 1847B60SDC | In distribution | ||
| 1847B40SDF | In distribution | ||
| 1847B30SCC | In distribution | ||
| 1847B40LDF | In distribution | ||
| 1847B15LCT | In distribution | ||
| 1847CV30LCT | In distribution | ||
| 1847B60SDX | In distribution | ||
| 1847B40SCF | In distribution | ||
| 1847B12LDM | In distribution | ||
| 1847B60SDM | In distribution | ||
| 1847B30LDF | In distribution | ||
| 1847B15LDC | In distribution | ||
| 1847ATTSV-R | In distribution | ||
| 1847B30SCT | In distribution | ||
| 1847B20SDC | In distribution | ||
| 1847B25SCF | In distribution | ||
| 1847B25LCT | In distribution | ||
| 1847CV30SDF | In distribution | ||
| 1847B50SCC | In distribution | ||
| 1847B50SDF | In distribution | ||
| 1847B20SCF | In distribution | ||
| 1847CV15LCT | In distribution | ||
| 1847B10SDC | In distribution | ||
| 1847B80SDM | In distribution | ||
| 1847B35LCT | In distribution | ||
| 1847CV40SDF | In distribution | ||
| 1847CV08SDF | In distribution | ||
| 1847B40LDM | In distribution | ||
| 1847B40SDX | In distribution | ||
| 1847B10SCT | In distribution | ||
| 1847B50SCC | In distribution | ||
| 1847B10SCC | In distribution | ||
| 1847B20LDM | In distribution | ||
| 1847B30SDM | In distribution | ||
| 1847B10LDF | In distribution | ||
| 1847B50LDF | In distribution | ||
| 1847B40SDF | In distribution | ||
| 1847B25SCT | In distribution | ||
| 1847B35SCT | In distribution | ||
| 1847B10SCC | In distribution | ||
| 1847ATTSS-R | In distribution | ||
| 1847CV10SDF | In distribution | ||
| 1847B20SCC | In distribution | ||
| 1847B40SCC | In distribution | ||
| 1847B70SDC | In distribution | ||
| 1847B35LDC | In distribution | ||
| 1847B80SCC | In distribution | ||
| 1847B20SCC | In distribution | ||
| 1847B30SDC | In distribution | ||
| 1847B06LDM | In distribution | ||
| 1847B30LDM | In distribution | ||
| 1847B60SCT | In distribution | ||
| 1847B10SCF | In distribution | ||
| 1847ATTSV | In distribution | ||
| 1847B35LDC | In distribution | ||
| 1847B10LDM | In distribution | ||
| 1847B60SDF | In distribution | ||
| 1847B70SDM | In distribution | ||
| 1847B40SCF | In distribution | ||
| 1847B35LDM | In distribution | ||
| 1847B80SCC | In distribution | ||
| 1847B15SDF | In distribution | ||
| 1847B15LDM | In distribution | ||
| 1847B80SDM | In distribution | ||
| 1847CV10SCT | In distribution | ||
| 1847B40SDM | In distribution | ||
| 1847B30LDF | In distribution | ||
| 1847B05LCT | In distribution | ||
| 1847B10LCT | In distribution | ||
| 1847B60SCF | In distribution | ||
| 1847B15LDM | In distribution | ||
| 1847CV15SDF | In distribution | ||
| 1847B70SCC | In distribution | ||
| 1847B10SDF | In distribution | ||
| 1847B20SDM | In distribution | ||
| 1847CV20SDC | In distribution | ||
| 1847B40SDC | In distribution | ||
| 1847B40LDF | In distribution | ||
| 1847B30SCF | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Anspach Effort, The | 214 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Karl Storz GmbH & Co. KG | 208 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Synthes Gmbh | 126 |
| Midas Rex | Medtronic Powered Surgical Solutions | 97 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Stryker GmbH | 87 |
| Midas REX Microsaws | Medtronic Powered Surgical Solutions | 75 |
| Piezomed Pro Accessory | W&H Dentalwerk Bürmoos GmbH | 50 |
| Midas Rex Clearview™ | Medtronic Xomed, Inc. | 47 |
| Zethon | Zethon Ltd | 39 |
| NSK Sterile Burs/Drills | Nakanishi Inc. | 34 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Medtronic Xomed, Inc. | 29 |
| Core | Stryker GmbH | 27 |
Showing 12 of 169. All products under Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
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.