Midas REX Microsaws
Blade 625R69-05-TB MR Recip 63X7X.5MM TB
2manufacturers in China registered for this device type
75catalogue 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) | K081475 |
| Record published | 2022-03-18 |
| Record revised | 2024-09-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 300S70-04 | In distribution | |
| 185S165-04F | In distribution | |
| R390-06 | In distribution | |
| ES300 | In distribution | |
| IRD410 | In distribution | |
| 625R69-05-TB | In distribution | |
| 320S50-04 | In distribution | |
| ES210 | In distribution | |
| 170S70-04F | In distribution | |
| R254-04F | In distribution | |
| 528R231-05 | In distribution | |
| 280S43-06F | In distribution | |
| 411R231-06 | In distribution | |
| 270S97-06F-ARC | In distribution | |
| 80SB150-04F | In distribution | |
| 360R146-03 | In distribution | |
| 250S55-04F | In distribution | |
| 200S95-04F | In distribution | |
| 150S40-03F | In distribution | |
| 350S90-06 | In distribution | |
| 345S130-05F | In distribution | |
| 180S55-04 | In distribution | |
| 310S50-06 | In distribution | |
| 185S165-05F | In distribution | |
| ES310 | In distribution | |
| 250S55-05 | In distribution | |
| 150S70-05F | In distribution | |
| 150S45-04F | In distribution | |
| R254-03F | In distribution | |
| 185S90-04 | In distribution | |
| 185S55-04F | In distribution | |
| RASP-ST-2 | In distribution | |
| 210SB90-06F-BAY | In distribution | |
| 523R345-06 | In distribution | |
| 310S90-05 | In distribution | |
| ES100 | In distribution | |
| R340-06F | In distribution | |
| 452R277-06 | In distribution | |
| 315S95-04F | In distribution | |
| 333R150-05 | In distribution | |
| 333R150-06 | In distribution | |
| 180S55-05F | In distribution | |
| 150S40-04F | In distribution | |
| 561R345-06-BAY | In distribution | |
| 250S90-04 | In distribution | |
| 115S55-04F | In distribution | |
| RASP-ST-1 | In distribution | |
| 625R345-05-BAY | In distribution | |
| 345S120-05 | In distribution | |
| 160SB90-06F-BAY | In distribution | |
| 180S102-03 | In distribution | |
| 185SB110-04-BAY | In distribution | |
| R250-03 | In distribution | |
| 310S90-04F | In distribution | |
| 594R277-05 | In distribution | |
| 310S90-04 | In distribution | |
| 549R231-05 | In distribution | |
| 460R277-06 | In distribution | |
| R340-04F | In distribution | |
| RASP-CC-2 | In distribution | |
| 130SB68-04F | In distribution | |
| 180S55-04F | In distribution | |
| 185S95-04F | In distribution | |
| 115S90-04F | In distribution | |
| 582R277-05 | In distribution | |
| 110S58-03-ARC | In distribution | |
| RASP-CC-1 | In distribution | |
| ES110 | In distribution | |
| 455R277-05 | In distribution | |
| 120S55-04F | In distribution | |
| 625R163-05F | In distribution | |
| 528R69-05-TB | In distribution | |
| 180S102-04 | In distribution | |
| 280S185-04 | In distribution | |
| 200S58-04-ARC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ENT MR8 | Medtronic Powered Surgical Solutions | 234 |
| 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 |
| 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
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Xomed, Inc. | 510(k) number | 2021-12-15 | Class II | Under Investigation by firm | As a result of Medtronic’s integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rota | 1447 units | 2023-06-09 |
| Medtronic Xomed, Inc. | 510(k) number | 2021-08-31 | Class II | Process control | There was an increase in complaints related to tip breaks and wobble/vibration. | 274,991 total devices | |
| Medtronic Powered Surgical Solutions | 510(k) number | 2016-05-13 | Class II | Device Design | Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use. | 368 devices | 2017-06-13 |
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.