Contoura - InMode RF™

Basic Information

• Brand Name: Contoura - InMode RF™
• Primary DI: 07290016633344
• Version / Model: InMode RF™ - Black-Blue
• Catalog Number: AG606970A
• Company Name: INMODE M.D LTD
• Labeler DUNS: 600417351
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-14
• Public Version: 5
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 26d41e7f-b3a3-416b-8ca2-e2fc9b3f31f8

Device Description

Contoura (InModeRF Color 3, Contura, Black-Blue)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35156	Percutaneous radio-frequency ablation system generator	An electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016633344	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K151793	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 90 – 110 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 30 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 110 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 0 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 65 Degrees Celsius