FDA.reportPublic FDA data

Moist 4.4 fl oz Water Based ANAL Bottle

Primary DI
00603912766172
Brand
Moist 4.4 fl oz Water Based ANAL Bottle
Company
PD Products, LLC
Model
Moist 4.4 fl oz Water Based ANAL Bottle
Catalog number
IDD11398
Device description
Moist 4.4 fl oz Water Based ANAL Bottle
Published
2023-04-12
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
K051295000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051295000I-D GLIDEWestridge Laboratories, Inc.2006-02-15NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30603912766173PackageGS112In Commercial Distribution
00603912766172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3060391276617330603912766173
00603912766172006039127661726039127661720603912766172

GMDN Terms#

Term, Definition table
TermDefinition
Sexual lubricantA 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.

Contacts#

Phone, Email table
PhoneEmail
7142599400service@westridgelabs.com

Regulatory Flags#

DUNS number
079188409
Device count
1
Lot or batch
true
Expiration date on label
true

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