SKYN

GUDID 00792554642002

SKYN Original Non-Latex Condom, 30ct

Mechanical Servants LLC

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