Device
Because performance gets better with the right glide.WETTERIS BETTERis a water-based lube gel specially formulated for use with Kaotik sextech. It delivers smooth lubrication and a...
Manufacturer
Shenzhen Yongquan Medical Devices Co., Ltd.
Model: 5.3FL.OZ/150g DI: 06959633106396 Status: Update MRI: MR Unsafe Single-use: Yes Rx: No OTC: No
First Published: 2026-05-07 Current Version: 2026-05-25
Description
Because performance gets better with the right glide.WETTERIS BETTERis a water-based lube gel specially formulated for use with Kaotik sextech. It delivers smooth lubrication and added moisturefora slick,responsive feelthat keeps every session moving.
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 2
Record Key: c739026e-ee3d-4c81-aa1c-2cd6ff35b557
Distribution Status: In Commercial Distribution
DUNS Number: 550369639
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: 06959633106396
Type: Primary
Issuing Agency: GS1
GMDN
Code: 34131
Name: Vaginal lubricant
Definition:
A non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.
FDA Product Codes
NUC
Lubricant, Personal
Premarket Submissions
Submission Number: K251773
Supplement Number: 000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit: Degrees Fahrenheit
Item #1 - Storage Handling Low - @attributes - Value: 56
Item #1 - Storage Handling High - @attributes - Unit: Degrees Fahrenheit
Item #1 - Storage Handling High - @attributes - Value: 86
Item #1 - Storage Handling Type: Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit: Degrees Fahrenheit
Item #2 - Storage Handling Low - @attributes - Value: 59
Item #2 - Storage Handling High - @attributes - Unit: Degrees Fahrenheit
Item #2 - Storage Handling High - @attributes - Value: 86
Item #2 - Storage Handling Type: Handling Environment Temperature