004® ZERO ZERO FOUR® Aloe Condoms

Basic Information

• Brand Name: 004® ZERO ZERO FOUR® Aloe Condoms
• Primary DI: 00028373050101
• Version / Model: 05010
• Catalog Number: 05010
• Company Name: OKAMOTO USA, INC.
• Labeler DUNS: 175752724
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 9de7ef52-0dd9-4451-a55b-42498211c899

Device Description

Natural rubber latex condom, lubricated with aloe extract, thin.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
HIS	Condom	Obstetrics/Gynecology	884.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45138	Basic male condom, Hevea-latex	A Hevea-latex rubber sheath 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	10028373050108	GS1	Shipper	48	In Commercial Distribution
Primary	00028373050101	GS1
Unit of Use	80028373050107	GS1

Customer Contacts

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