Peekay Lover's Water Based 10ml Foil

GUDID 10796494003005

Water-based Personal Lubricant

CC Wellness LLC

Sexual lubricant
Primary Device ID10796494003005
NIH Device Record Key16294cb2-cacc-4ed6-87fc-fd551820de04
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeekay Lover's Water Based 10ml Foil
Version Model Number79050-IH
Company DUNS067692292
Company NameCC Wellness 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100796494003008 [Primary]
GS110796494003005 [Package]
Contains: 00796494003008
Package: [250 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-22
Device Publish Date2023-05-12