BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

InMode RF Multi-System

DI: 07290016633320 · Model: AG606968A · INMODE M.D LTD

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: InMode RF Multi-System
Primary DI: 07290016633320
Version / Model: AG606968A
Catalog Number: AG606968A
Company Name: INMODE M.D LTD
Labeler DUNS: 600417351
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2022-10-26
Public Version: 1
Public Version Date: 2022-11-03
Public Version Status: New
Public Device Record Key: 9b74df93-c1a7-415c-bc5a-3bcfd9695581

Device Description

InModeRF Color 1, Black-Purple

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: Yes
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	07290016633320	GS1

Customer Contacts

Phone: 18873674556
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K201150	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