SKYN

GUDID 00792554642002

SKYN Original Non-Latex Condom, 30ct

Mechanical Servants LLC

Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer

• Primary Device ID: 00792554642002
• NIH Device Record Key: b3e2a52c-a460-4cfd-ae34-24ec423232ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKYN
• Version Model Number: 210100
• 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00792554642002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171172

FDA Product Code

• MOL: Condom, Synthetic

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

Devices Manufactured by Mechanical Servants LLC

• 00792554642002 - SKYN: 2022-11-14SKYN Original Non-Latex Condom, 30ct
• 00792554642002 - SKYN: 2022-11-14 SKYN Original Non-Latex Condom, 30ct
• 00792554643009 - LIFESTYLES: 2022-11-14 Lifestyles Ultra-Ribbed Latex Condom, 30ct
• 00792554643016 - LIFESTYLES: 2022-11-14 Lifestyles Large Latex Condom, 30ct