KY Intense Pleasure Gel

GUDID 20067981952296

Personal Lubricant

RB Health (us) LLC

Vaginal lubricant
Primary Device ID20067981952296
NIH Device Record Key7917587c-637b-4ddc-aac9-b4835ec2cd19
Commercial Distribution StatusIn Commercial Distribution
Brand NameKY Intense Pleasure Gel
Version Model NumberPersonal Lubricant
Company DUNS081049410
Company NameRB Health (us) LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)756-5488
Emailxxx@xxx.xxx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place away from direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100067981952292 [Primary]
GS110067981952299 [Package]
Contains: 00067981952292
Package: Carton [4 Units]
In Commercial Distribution
GS120067981952296 [Package]
Contains: 10067981952299
Package: Case [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUCLubricant, personal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-24
Device Publish Date2016-09-20

On-Brand Devices [KY Intense Pleasure Gel]

20067981952296Personal Lubricant
20067981972867Personal Lubricant
10067981088035Personal Lubricant 0.34 oz. Target-00067981972863 Retail-00067981952292

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