SKYN 90200

GUDID 00792554902007

SKYN Original Non-Latex Condom,3ct

Lil' Drug Store Products, Inc.

Basic male condom, synthetic polymer

• Primary Device ID: 00792554902007
• NIH Device Record Key: 3a645c02-2c63-4a4f-bef5-d14195e29036
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKYN
• Version Model Number: 210100
• Catalog Number: 90200
• Company DUNS: 093103646
• Company Name: Lil' Drug Store Products, Inc.
• 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	00792554902007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171172

FDA Product Code

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