Spice Up Your Sex Life

GUDID 20860000864804

Spice Up Plain Male Condom

SPICE UP ENTERTAINMENT LLC

Basic male condom, Hevea-latex

• Primary Device ID: 20860000864804
• NIH Device Record Key: e0b743c7-408b-4e5d-9cab-3210c7383bee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spice Up Your Sex Life
• Version Model Number: SU8793
• Company DUNS: 116915487
• Company Name: SPICE UP ENTERTAINMENT 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000864800 [Primary]
GS1	10860000864807 [Package]; Contains: 00860000864800; Package: Inner Pack [12 Units]; In Commercial Distribution
GS1	20860000864804 [Package]; Contains: 10860000864807; Package: Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002571

FDA Product Code

• HIS: Condom

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-18
• Device Publish Date: 2019-01-16