HANX

Basic Information

• Brand Name: HANX
• Primary DI: 05060703560398
• Version / Model: 10 Pack Large Size
• Company Name: HANX LIMITED
• Labeler DUNS: 221266506
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2024-01-05
• Public Version: 1
• Public Version Date: 2024-01-15
• Public Version Status: New
• Public Device Record Key: 8b22235a-4b8a-4c3b-a9da-98120b241d50

Device Description

HANX Condoms, Large Size, Ultra-thin, Vegan, 10-pack.

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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	05060703560428	GS1	Box	6	In Commercial Distribution
Primary	05060703560398	GS1
Unit of Use	05060703560855	GS1

Device Sizes

Type	Value	Unit	Text
Length	195	Millimeter
Width	56	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in cool, dry place away from direct sunlight and heat