LifeStyles Ultra Sensitive Platinum

GUDID 30070907201795

LifeStyles Ultra Sensitive Platinum Lubricated Natural Rubber Latex Condoms-12 count

SURETEX LIMITED - BRANCH

Basic male condom, Hevea-latex

• Primary Device ID: 30070907201795
• NIH Device Record Key: d0d41710-04d1-4e5d-b70a-2a20a4a363d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeStyles Ultra Sensitive Platinum
• Version Model Number: 0179
• Company DUNS: 672044515
• Company Name: SURETEX LIMITED - BRANCH
• Device Count: 12
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00070907201794 [Primary]
GS1	10070907201791 [Package]; Contains: 00070907201794; Package: inner [4 Units]; In Commercial Distribution
GS1	30070907201795 [Package]; Contains: 10070907201791; Package: case [6 Units]; In Commercial Distribution
GS1	80070907701078 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163107

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: 2019-05-16
• Device Publish Date: 2019-05-08

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