stratosphere

Basic Information

• Brand Name: stratosphere
• Primary DI: 04262384030004
• Version / Model: 24
• Catalog Number: TMSTR01
• Company Name: Saxony Beauty Technology GmbH
• Labeler DUNS: 313345439
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-11
• Public Version: 1
• Public Version Date: 2023-04-19
• Public Version Status: New
• Public Device Record Key: 20b89dd7-0678-4630-b252-fa7cda1804ea

Device Description

Massager for body sculpting and anti-cellulite procedures.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04262384030004	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	50	Centimeter
Width	41	Centimeter
Height	101	Centimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -50 – 50 Degrees Celsius