Philly

GUDID 28859798104997

Custom Condom Philly Flared

SURETEX LIMITED - BRANCH

Basic male condom, Hevea-latex

• Primary Device ID: 28859798104997
• NIH Device Record Key: d8ad0cb3-5ba3-4eca-8045-3368ee4e7fec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philly
• Version Model Number: 08859798104993
• Company DUNS: 672044515
• Company Name: SURETEX LIMITED - BRANCH
• Device Count: 1008
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08859798104993 [Primary]
GS1	28859798104997 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941258

FDA Product Code

• HIS: Condom

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-07
• Device Publish Date: 2025-07-30

Devices Manufactured by SURETEX LIMITED - BRANCH

• 28859798106977 - SKYN: 2025-09-12 SKYN Supreme Feel Extra Lubricated Non-Latex Condom BX08
• 18859798107267 - LIFESTYLES: 2025-09-12 LifeStyles Snugger Fit Latex Condom BX100 AMZ Exclusive RP
• 18859798107274 - LIFESTYLES: 2025-09-12 LifeStyles Ultra Thin Latex Condom BX50
• 18859798107281 - LIFESTYLES: 2025-09-12 LifeStyles Tough Latex Condom BX48
• 18859798107298 - LIFESTYLES: 2025-09-12 LifeStyles Non Lubricated Latex Condoms BX100
• 18859798107311 - SKYN: 2025-09-12 SKYN COCKTAIL CLUB 36CT (CHERRY SUNRISE, PASSION DAIQUIRI, PINA COLADA)
• 18859798107328 - SKYN: 2025-09-12 SKYN SNUG 40CT
• 18859798107380 - LIFESTYLES: 2025-09-12 LifeStyles Ultra Sensitive Latex Condom 1008 RP