Midas Rex®
GUDID 00613994633897
MOTOR EM210 LEGEND EHS STYLUS TOUCH
MEDTRONIC XOMED, INC.
Multi-purpose surgical power tool system, line-powered Multi-purpose surgical power tool system, line-powered Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic| Primary Device ID | 00613994633897 |
| NIH Device Record Key | 6f69ef37-d1df-462f-bdc9-6b91e11a05a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Midas Rex® |
| Version Model Number | EM210 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994633897 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K081475
FDA Product Code
| HBE | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00613994633897]
Moist Heat or Steam Sterilization;Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-22 |
| Device Publish Date | 2016-09-29 |
On-Brand Devices [Midas Rex®]
| 00613994633897 | MOTOR EM210 LEGEND EHS STYLUS TOUCH |
| 00613994614605 | HANDPIECE ED100RF SC1 REFURB |
| 00613994550446 | SC1 HANDPIECE ED100LO LOANER |
| 00643169945388 | MOTOR EM210 LEGEND EHS STYLUS TOUCH ROHS |
| 00643169945371 | MOTOR EM210RF LEGEND STYLUS TOUCH REFURB |
| 00643169931459 | CONSOLE EC300RF IPC REFURB |
| 00643169882805 | HANDPIECE ED100RF SC1 REFURB |
| 00643169882720 | SC1 HANDPIECE ED100 ROHS |
| 00643169360976 | MOTOR EM210 LEGEND EHS STYLUS TOUCH ROHS |
| 00643169350694 | SC1 HANDPIECE ED100 ROHS |
Trademark Results [Midas Rex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MIDAS REX 88604073 not registered Live/Pending |
Medtronic, Inc. 2019-09-04 |
 MIDAS REX 74274596 1749994 Dead/Cancelled |
MEDTRONIC, INC. 1992-05-12 |
 MIDAS REX 73778773 1563872 Live/Registered |
MIDAS REX PNEUMATIC TOOLS, INC. 1989-02-06 |
 MIDAS REX 73590429 1435398 Live/Registered |
MIDAS REX PNEUMATIC TOOLS, INC. 1986-03-28 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.