KY True Feel Premium Silicone Lubricant

GUDID 20067981087899

Personal Lubricant

RB Health (us) LLC

Vaginal lubricant
Primary Device ID20067981087899
NIH Device Record Keycde32357-c462-48de-a137-cbc26caf49f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameKY True Feel Premium Silicone Lubricant
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
Email[email protected]

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
GS100067981087895 [Primary]
GS110067981087892 [Package]
Contains: 00067981087895
Package: Carton [6 Units]
In Commercial Distribution
GS120067981087899 [Package]
Contains: 10067981087892
Package: Case [4 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 Date2019-11-27
Device Publish Date2019-11-19

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