Silk'n

Basic Information

• Brand Name: Silk'n
• Primary DI: 17290112450064
• Version / Model: Tightra NA
• Catalog Number: 7290112450067
• Company Name: HOME SKINOVATIONS LTD
• Labeler DUNS: 514891048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-04
• Public Version: 2
• Public Version Date: 2023-05-04
• Public Version Status: Update
• Public Device Record Key: 08e540a6-47f6-4fd4-94bb-a18429b8c836

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: 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
KXQ	Vibrator For Therapeutic Use, Genital	Obstetrics/Gynecology	884.5960	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33728	Penile sexual vibrator	A noninvasive, electronic device intended to use vibratory stimuli to facilitate male orgasm and/or ejaculation, including for the treatment/control of male sexual disorders (e.g., premature ejaculation); it does not include sexual lubricant or additional accessory devices. It may be used in the presence of a limiting disability, such as spinal cord injury. It may also be used as an adjunct in the treatment of tightening the muscles of the pelvic floor to increase muscle tone (Kegel's exercise).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	07290112450067	GS1
Primary	17290112450064	GS1
Package	37290112450068	GS1	Box	1	In Commercial Distribution
Package	27290112450061	GS1	Box	4	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius