LIFESTYLES 64300

GUDID 00792554643009

Lifestyles Ultra-Ribbed Latex Condom, 30ct

Mechanical Servants LLC

Basic male condom, Hevea-latex

• Primary Device ID: 00792554643009
• NIH Device Record Key: 33384f1e-6454-4f93-8d52-b13fab2b2d27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIFESTYLES
• Version Model Number: 832389
• Catalog Number: 64300
• Company DUNS: 005530951
• Company Name: Mechanical Servants LLC
• Device Count: 1
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00792554643009 [Primary]

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: 2022-11-14
• Device Publish Date: 2022-11-04

On-Brand Devices [LIFESTYLES]

• 00792554643016: Lifestyles Large Latex Condom, 30ct
• 00792554643009: Lifestyles Ultra-Ribbed Latex Condom, 30ct