Morpheus8

Basic Information

• Brand Name: Morpheus8
• Primary DI: 07290016633627
• Version / Model: AG609135A
• Catalog Number: AG609135A
• Company Name: INMODE M.D LTD
• Labeler DUNS: 600417351
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-27
• Public Version: 1
• Public Version Date: 2022-11-04
• Public Version Status: New
• Public Device Record Key: 8d78ec7a-a4de-410d-be94-0605dd6eb131

Device Description

Morpheus8 Body 40p Tip

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
45048	Radio-frequency skin contouring system applicator tip	A removable endpiece that is attached to a radio-frequency (RF) skin contouring system applicator (handpiece), used to regulate the delivery of RF energy to the patient during treatment. As a procedural safety measure, the device may permit the transfer of energy only when a correct surface contact is established. It may also be used to cool the skin and monitor its temperature to protect the epidermis during treatment. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016633627	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K192695	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 110 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 90 – 110 KiloPascal