Ultra Shape Colors

GUDID 18859798104921

Ultra Shape Colors

SURETEX LIMITED - BRANCH

Basic male condom, Hevea-latex
Primary Device ID18859798104921
NIH Device Record Keye63b1136-4a4b-446d-b7cd-4a0cf4804602
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltra Shape Colors
Version Model Number08859798104924
Company DUNS672044515
Company NameSURETEX LIMITED - BRANCH
Device Count1008
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8482293224
Emailalexandra.kirkland@lifestyles.com
Phone8482293224
Emailalexandra.kirkland@lifestyles.com
Phone8482293224
Emailalexandra.kirkland@lifestyles.com
Phone8482293224
Emailalexandra.kirkland@lifestyles.com
Phone8482293224
Emailalexandra.kirkland@lifestyles.com
Phone8482293224
Emailalexandra.kirkland@lifestyles.com
Phone8482293224
Emailalexandra.kirkland@lifestyles.com
Phone8482293224
Emailalexandra.kirkland@lifestyles.com
Phone8482293224
Emailalexandra.kirkland@lifestyles.com
Phone8482293224
Emailalexandra.kirkland@lifestyles.com
Phone8482293224
Emailalexandra.kirkland@lifestyles.com
Phone8482293224
Emailalexandra.kirkland@lifestyles.com
Phone8482293224
Emailalexandra.kirkland@lifestyles.com
Phone8482293224
Emailalexandra.kirkland@lifestyles.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108859798104924 [Primary]
GS118859798104921 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HISCondom

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-31
Device Publish Date2024-10-23

Devices Manufactured by SURETEX LIMITED - BRANCH

28859798106977 - SKYN2025-09-12 SKYN Supreme Feel Extra Lubricated Non-Latex Condom BX08
18859798107267 - LIFESTYLES2025-09-12 LifeStyles Snugger Fit Latex Condom BX100 AMZ Exclusive RP
18859798107274 - LIFESTYLES2025-09-12 LifeStyles Ultra Thin Latex Condom BX50
18859798107281 - LIFESTYLES2025-09-12 LifeStyles Tough Latex Condom BX48
18859798107298 - LIFESTYLES2025-09-12 LifeStyles Non Lubricated Latex Condoms BX100
18859798107311 - SKYN2025-09-12 SKYN COCKTAIL CLUB 36CT (CHERRY SUNRISE, PASSION DAIQUIRI, PINA COLADA)
18859798107328 - SKYN2025-09-12 SKYN SNUG 40CT
18859798107380 - LIFESTYLES2025-09-12 LifeStyles Ultra Sensitive Latex Condom 1008 RP

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