LubeLab Premium Silicone-based Personal Lubricant

GUDID 00850030994028

SILICONE Personal Lubricant 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 latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Premium Natural Cosmetics Inc.

Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant
Primary Device ID00850030994028
NIH Device Record Keyf0bd4a1e-0b34-4b0e-a7b2-ed46c258bd93
Commercial Distribution StatusIn Commercial Distribution
Brand NameLubeLab Premium Silicone-based Personal Lubricant
Version Model Number00850030994028
Company DUNS051403646
Company NamePremium Natural Cosmetics Inc.
Device Count1
DM Exempttrue
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 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
GS100850030994028 [Primary]

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 Date2021-07-28
Device Publish Date2021-07-20

Devices Manufactured by Premium Natural Cosmetics Inc.

00850030994028 - LubeLab Premium Silicone-based Personal Lubricant2021-07-28SILICONE Personal Lubricant 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 latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
00850030994028 - LubeLab Premium Silicone-based Personal Lubricant2021-07-28 SILICONE Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate
00860006114107 - Intimaterial Silicone Personal Lubricant2021-01-11 SILICONE Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate

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