SKYN 90202

GUDID 00792554902021

SKYN Elite Large Non-Latex Condom, 3ct

Lil' Drug Store Products, Inc.

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

• Primary Device ID: 00792554902021
• NIH Device Record Key: 57b0a5ce-da5b-44bd-bb3c-22ff38a26a05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKYN
• Version Model Number: 210124
• Catalog Number: 90202
• Company DUNS: 093103646
• Company Name: Lil' Drug Store Products, Inc.
• Device Count: 1
• DM Exempt: true
• 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	00792554902021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171172

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: 2022-09-20
• Device Publish Date: 2022-09-12