DUREX Avanti Bare- RealFeel Non-Latex Condom

Basic Information

• Brand Name: DUREX Avanti Bare- RealFeel Non-Latex Condom
• Primary DI: 88302340894553
• Version / Model: Condom
• Company Name: RB Health (us) LLC
• Labeler DUNS: 081049410
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 5
• Public Version Date: 2023-07-12
• Public Version Status: Update
• Public Device Record Key: 59758a5a-7065-4dc5-804c-32e8b3ed0329
• Distribution End Date: 2023-07-10

Device Description

Condom

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: 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
Package	20302340894559	GS1	Case	24	Not in Commercial Distribution	2023-07-10
Package	10302340894552	GS1	Carton	6	Not in Commercial Distribution	2023-07-10
Primary	88302340894553	GS1
Unit of Use	40302340894553	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K072169	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat