Midas Rex®
GUDID 00613994633897
MOTOR EM210 LEGEND EHS STYLUS TOUCH
MEDTRONIC XOMED, INC.
Multi-purpose surgical power tool system, line-powered| 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 |
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