pjur INFINITY silicone-based 13967-02

GUDID 10827160115163

Silicone-based Personal Lubricant

Pjur Group Luxembourg SA

Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant

• Primary Device ID: 10827160115163
• NIH Device Record Key: 87da70db-879e-4246-b4b3-cf52fa66046f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pjur INFINITY silicone-based
• Version Model Number: pjur INFINITY silicone-based, 50ml
• Catalog Number: 13967-02
• Company DUNS: 400744553
• Company Name: Pjur Group Luxembourg SA
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827160115166 [Primary]
GS1	10827160115163 [Package]; Contains: 00827160115166; Package: pack [6 Units]; In Commercial Distribution
GS1	40827160115164 [Package]; Package: case [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133336

FDA Product Code

• NUC: Lubricant, Personal

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: 2022-10-03
• Device Publish Date: 2022-09-23

On-Brand Devices [pjur INFINITY silicone-based ]

• 10827160115163: Silicone-based Personal Lubricant
• 10827160115255: Silicone-based Personal Lubricant