Model: 53mm,condom(Dotted)
DI: 06936296747166
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-11
Current Version: 2026-05-19
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f9c391e9-ba21-4524-9619-c739a29e7b4b
Distribution Status:
In Commercial Distribution
DUNS Number:
529430956
Device Count:
1
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:
Carton
Item #1 - Device ID:
16936296747163
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
3
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
06936296747166
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
06936296747166
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Case
Item #3 - Device ID:
26936296747160
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
400
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
16936296747163
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
Premarket Submissions
Submission Number:
K220576
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Type:
Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text:
Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.