Model: 08859798108724
DI: 08859798108724
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
SKYN Elite Non-Latex Condom 3ct
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
761a77cc-066f-4d40-aa9c-0ef60470ca0e
Distribution Status:
In Commercial Distribution
DUNS Number:
672044515
Device Count:
3
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:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Device ID:
28859798108728
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
08859798108724
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 34151
Name: Basic male condom, synthetic polymer
Definition:
A sheath made from synthetic polymers (e.g., polyurethane, polyisoprene) 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
MOL
Condom, Synthetic
Premarket Submissions
Submission Number:
K171172
Supplement Number:
000