KY True Feel Premium Silicone Lubricant

GUDID 10067981953975

Personal Lubricant

RB Health (us) LLC

Vaginal lubricant
Primary Device ID10067981953975
NIH Device Record Key982a9f86-3a3a-48e1-bdcf-403ecfd4d3ce
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
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
GS100067981953978 [Primary]
GS110067981953975 [Package]
Contains: 00067981953978
Package: Carton [6 Units]
In Commercial Distribution
GS120067981953972 [Package]
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 StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-11-06
Device Publish Date2016-09-20

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77067981953970Personal Lubricant

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