Model: Model A, 120g
DI: 06936684210098
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
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9f3c00a0-4505-45ba-9c21-ecd9ed3bd7bf
Distribution Status:
In Commercial Distribution
DUNS Number:
546985679
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:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06936684210098
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
Premarket Submissions
Submission Number:
K253983
Supplement Number:
000