Device
1
Manufacturer
EDEN PARTNERS LLC
Model: 1 DI: 00810082871241 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: Yes
First Published: 2026-04-30 Current Version: 2026-05-08
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: f3362da7-f7f3-425b-ad67-8e9e762ee001
Distribution Status: In Commercial Distribution
DUNS Number: 114036824
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: No
Labeled No NRL: No
Identifiers
Device ID: 00810082871241
Type: Primary
Issuing Agency: GS1
GMDN
Code: 60412
Name: Sexual lubricant
Definition:
A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.
FDA Product Codes
NUC
Lubricant, Personal