DUOLITH®

Basic Information

• Brand Name: DUOLITH®
• Primary DI: 07630039101343
• Version / Model: SD1 R-SW
• Catalog Number: 19880.0006
• Company Name: Storz Medical AG
• Labeler DUNS: 481967776
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-01
• Public Version: 1
• Public Version Date: 2021-06-09
• Public Version Status: New
• Public Device Record Key: 19e9d7db-736f-4310-a637-76b982337df2

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
ISA	Massager, Therapeutic, Electric	Physical Medicine	890.5660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36560	Hand-held electric massager	An electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.	No	Active
47979	Pressure-wave skin contouring system	An assembly of devices using extracorporeal pulse activation technology (EPAT) and designed for acoustic wave treatment (AWT) intended primarily to reduce the appearance of cellulite through mobilization of free fatty acids and oxidative agents in tissue. It typically consists of a control unit that produces pneumatically-generated and/or electrically-generated pressure waves at selected impulse frequencies by means of one or more hand-held, skin-surface applicators. The system may also be used to treat the skin, e.g., by smoothing wrinkles, tightening muscle/connective tissue, and/or improving lymphatic drainage; it may also be used to treat minor muscle pain.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07630039101343	GS1

Premarket Submissions

Submission Number	Supplement Number
K173692	000