ONE Super Sensitive

Basic Information

• Brand Name: ONE Super Sensitive
• Primary DI: 00726893116030
• Version / Model: 11603
• Company Name: GLOBAL PROTECTION CORP.
• Labeler DUNS: 364614362
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2020-06-01
• Public Version: 2
• Public Version Date: 2022-04-21
• Public Version Status: Update
• Public Device Record Key: 80be8cc6-f9e9-4961-8a2c-393e580656d6

Device Description

3 Lubricated male Latex Condoms

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• 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
QRZ	External Condom For Anal Intercourse Or Vaginal Intercourse	Obstetrics/Gynecology	884.5305	2
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	10726893116037	GS1	bundle of 6, 3 pack	6	In Commercial Distribution
Primary	00726893116030	GS1
Package	20726893116034	GS1	24 bundles of 6	24	In Commercial Distribution
Unit of Use	80726893111857	GS1

Customer Contacts

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