MIDAS REX®
GUDID 00643169882720
SC1 HANDPIECE ED100 ROHS
MEDTRONIC XOMED, INC.
Multi-purpose surgical power tool system, line-powered| Primary Device ID | 00643169882720 |
| NIH Device Record Key | c4479b4a-f062-47e9-bf84-25b2037b5d60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MIDAS REX® |
| Version Model Number | ED100 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169882720 [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 |
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169882720]
Ethylene Oxide;Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-11-22 |
| Device Publish Date | 2018-06-11 |
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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