Nimbus Probe (Reusable)

GUDID 05060224331644

Reusable RF Thermocouple Electrode

Stratus Medical LLC

Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable

• Primary Device ID: 05060224331644
• NIH Device Record Key: 98c2c436-1d35-4a95-8dd8-f452012cf91f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nimbus Probe (Reusable)
• Version Model Number: NRP-50-27-N-CE
• Company DUNS: 117402924
• Company Name: Stratus Medical LLC
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060224331644 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090608

FDA Product Code

• GXI: Probe, Radiofrequency Lesion

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[05060224331644]

Moist Heat or Steam Sterilization

[05060224331644]

Moist Heat or Steam Sterilization

[05060224331644]

Moist Heat or Steam Sterilization

[05060224331644]

Moist Heat or Steam Sterilization

[05060224331644]

Moist Heat or Steam Sterilization

[05060224331644]

Moist Heat or Steam Sterilization

[05060224331644]

Moist Heat or Steam Sterilization

[05060224331644]

Moist Heat or Steam Sterilization

[05060224331644]

Moist Heat or Steam Sterilization

[05060224331644]

Moist Heat or Steam Sterilization

[05060224331644]

Moist Heat or Steam Sterilization

[05060224331644]

Moist Heat or Steam Sterilization

[05060224331644]

Moist Heat or Steam Sterilization

[05060224331644]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-21
• Device Publish Date: 2022-09-13

On-Brand Devices [Nimbus Probe (Reusable)]

• 05060224331958: Reusable RF Thermocouple Electrode
• 05060224331941: Reusable RF Thermocouple Electrode
• 05060224331934: Reusable RF Thermocouple Electrode
• 05060224331668: Reusable RF Thermocouple Electrode
• 05060224331651: Reusable RF Thermocouple Electrode
• 05060224331644: Reusable RF Thermocouple Electrode