XPS Nexus™
GUDID 00763000007454
CONSOLE 1894510 XPS NEXUS W/PUMP ROHS
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 | 00763000007454 |
| NIH Device Record Key | 483fe59c-f09a-47a9-b54b-d9afceabbb4d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XPS Nexus™ |
| Version Model Number | 1894510 |
| 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 | 00763000007454 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150728
FDA Product Code
| ERL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-11-22 |
| Device Publish Date | 2018-08-19 |
On-Brand Devices [XPS Nexus™]
| 00643169434141 | FOOT CONTROL 1894520 XPS NEXUS ROHS |
| 00643169434134 | CONSOLE 1894510 XPS NEXUS W/PUMP ROHS |
| 00763000007461 | FOOT CONTROL 1894520 XPS NEXUS ROHS |
| 00763000007454 | CONSOLE 1894510 XPS NEXUS W/PUMP ROHS |
Trademark Results [XPS Nexus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XPS NEXUS 86130540 4937190 Live/Registered |
Medtronic Xomed, Inc. 2013-11-27 |
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