KY UltraGel

GUDID 99067981993756

Lubricant

RB Health (us) LLC

Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant
Primary Device ID99067981993756
NIH Device Record Keyebb74ba0-737a-43b1-959a-80de645fa0c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameKY UltraGel
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 Usetrue
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

Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS100067981993752 [Package]
Package: Carton [1 Units]
In Commercial Distribution
GS110067981993759 [Package]
Contains: 00067981993752
Package: Case [24 Units]
In Commercial Distribution
GS199067981993756 [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 Date2023-04-12
Device Publish Date2023-04-04

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