Nimbus

GUDID 10850040767015

Electrosurgical RF Multitined Expandable Electrode

Stratus Medical LLC

Percutaneous radio-frequency ablation system probe cannula, single-use

• Primary Device ID: 10850040767015
• NIH Device Record Key: 9d8648f0-ea13-40fc-af9a-8a6eafe60fd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nimbus
• Version Model Number: NIM-100-10BB-CS
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850040767018 [Primary]
GS1	10850040767015 [Package]; Contains: 00850040767018; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121773

FDA Product Code

• GXI: Probe, Radiofrequency Lesion

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: 2022-09-20
• Device Publish Date: 2022-09-12

On-Brand Devices [Nimbus]

• 10850040767039: Electrosurgical RF Multitined Expandable Electrode
• 10850040767022: Electrosurgical RF Multitined Expandable Electrode
• 10850040767015: Electrosurgical RF Multitined Expandable Electrode
• 10850040767008: Electrosurgical RF Multitined Expandable Electrode