PlasmaBlade™ X

GUDID 00763000279172

PLASMABLADE X PS210-030S-LIGHT 3.0SL

MEDTRONIC NAVIGATION, INC.

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 00763000279172
• NIH Device Record Key: dd9d5da7-9885-4ed4-b63d-afab40a8ab2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PlasmaBlade™ X
• Version Model Number: PS210-030S-LIGHT
• 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
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000279172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193579

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: 2020-05-18
• Device Publish Date: 2020-05-10

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