Injectable RF Electrode

GUDID 00817371020243

Thermi

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

• Primary Device ID: 00817371020243
• NIH Device Record Key: dafce8e5-f0f7-44b5-b697-074bd0c8751a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Injectable RF Electrode
• Version Model Number: V-5-5-20-B
• Company DUNS: 021008486
• Company Name: Thermi
• 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	00817371020243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170116

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00817371020243]

Radiation Sterilization

[00817371020243]

Radiation Sterilization

[00817371020243]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-09-20

On-Brand Devices [Injectable RF Electrode]

• 00817371020243: V-5-5-20-B
• 00817371020236: V--20-10-16-B
• 00817371020229: V-15-10-18-B
• 00817371020212: Disposable Radiofrequency Cannula Electrode