PlasmaBlade™ X
GUDID 00643169936638
PLASMABLADE X PS200-040 4.0 PINK
MEDTRONIC NAVIGATION, INC.
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use| Primary Device ID | 00643169936638 |
| NIH Device Record Key | ca157d78-6e78-46d3-818e-5adf3914fee1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PlasmaBlade™ X |
| Version Model Number | PS200-040 |
| Company DUNS | 835233107 |
| Company Name | MEDTRONIC NAVIGATION, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169936638 [Primary] |
FDA Product Code
| GEI | Electrosurgical, cutting & coagulation & accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-03 |
| Device Publish Date | 2020-06-25 |
On-Brand Devices [PlasmaBlade™ X]
| 00763000279189 | PLASMABLADEX PS210-030S-LIGHT 3.0SL PINK |
| 00763000279172 | PLASMABLADE X PS210-030S-LIGHT 3.0SL |
| 00763000279165 | PLASMABLADE X PS210-030S-LIGHT 3.0SL |
| 00763000279141 | PLASMABLADE X PS200-041S 4.0S GREEN |
| 00763000059880 | PLASMABLADE X PS200-041S 4.0S PINK |
| 00763000059842 | PLASMABLADE X PS200-040 4.0 GREEN |
| 00763000059811 | PLASMABLADE X PS210-030S 3.0S GREEN |
| 00643169936683 | PLASMABLADE X PS210-030S PINK |
| 00643169936638 | PLASMABLADE X PS200-040 4.0 PINK |
| 00763000059873 | PLASMABLADE X PS200-041S 4.0S |
Trademark Results [PlasmaBlade]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PLASMABLADE 86271763 4652853 Live/Registered |
Medtronic Advanced Energy LLC 2014-05-05 |
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