Model: 112509
DI: 00726893120440
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-04-24
Current Version: 2026-05-04
Description
A lubricated Latex Condom
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
47e51341-7a1c-4d82-9c0e-89788b82b113
Distribution Status:
In Commercial Distribution
DUNS Number:
364614362
Device Count:
36
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
Yes
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Case of 24
Item #1 - Device ID:
20726893120444
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
36
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00726893120440
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00726893120440
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
80726893120446
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 45138
Name: Basic male condom, Hevea-latex
Definition:
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.
FDA Product Codes
HIS
Condom
Environmental Conditions
Storage Handling - Storage Handling Type:
Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text:
Store at room temperature in a dark, dry place. Avoid excessive heat.