LifeStyles SKYN Original 40 ct Bowl

Basic Information

• Brand Name: LifeStyles SKYN Original 40 ct Bowl
• Primary DI: 00813356000200
• Version / Model: 813356000200
• Company Name: PARADISE MARKETING SERVICES, A CALIFORNIA CORPORATION
• Labeler DUNS: 038573838
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-21
• Public Version: 1
• Public Version Date: 2019-01-21
• Public Version Status: New
• Public Device Record Key: af9922ca-5283-480d-9ead-faf7245118ae

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MOL	Condom, Synthetic	Obstetrics/Gynecology	884.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34151	Basic male condom, synthetic polymer	A sheath made from synthetic polymers (e.g., polyurethane, polyisoprene) intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813356000200	GS1

Premarket Submissions

Submission Number	Supplement Number
K160399	000