FDA.reportPublic FDA data

WET Original Gel Lubricant

Primary DI
00716222241007
Brand
WET Original Gel Lubricant
Company
Trigg Laboratories, Inc.
Model
24100
Catalog number
24100
Device description
WET® ORIGINAL® is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Reapply as desired.
Published
2017-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160211000Wet Original Personal LubricantTrigg Laboratories D/B/A Wet International2016-04-27NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00716222241007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00716222241007007162222410077162222410070716222241007

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal lubricantA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
661-775-3100erniej@trigglabs.com
7029574400marlab@trigglabs.com

Regulatory Flags#

DUNS number
618973077
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00716222264136Wet Chocolate Flavored Lubricant26413264132025-11-12
00716222216432Wet Flavored Lubricant21643216432025-11-10
00716222264099Wet Flavored Lubricant26409264092025-10-10
00716222203661WET Light Liquid Lubricant20366203662019-03-18
00716222203067WET Water20306203062023-09-23
00716222203081WET Water20308203082023-09-23
00716222203104WET Water20310203102023-09-23
00716222203128WET Water20312203122023-09-23
00716222203142WET Water20314203142023-09-23
00716222203166WET Water20316203162023-09-23
00716222203180WET Water20318203182023-09-23
00716222207317WET Hybrid 20731207312023-09-23
00716222207324WET Hybrid 20732207322023-09-23
00716222207331WET Hybrid 20733207332023-09-23
00716222207348WET Hybrid 20734207342023-09-23
00716222207522Wet Platinum Silicone Lubricant20752207522023-09-23
00716222215176Wet Flavored Lubricant21517215172023-09-23
00716222215237Wet Flavored Lubricant21523215232023-09-23
00716222215251Wet Flavored Lubricant21525215252023-09-23
00716222215275Wet Flavored Lubricant21527215272023-09-23

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00787651760643AZOi-Health, Inc.NUC2026-05-29
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08859798108090LIFESTYLESSURETEX LIMITED - BRANCHNUC2026-01-27
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