Model: PTBB2Z
DI: 00860014330308
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-15
Current Version: 2026-05-25
Description
Water-based personal lubricant
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b3815155-d527-44ff-bd30-16bfdf034b90
Distribution Status:
In Commercial Distribution
DUNS Number:
135658541
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
Item #1 - Device ID:
00860014330308
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10860014330305
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
12
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
00860014330308
Item #2 - Device ID 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
PEB
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible